Advancing Cutting Edge Research Act

S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.3692, S.2317 - Addiction Treatment Access Improvement Act of 2017 HR6, SUPPORT for Patients and Communities Act (Public Law No: 115-271) H.R. 5102, S. 2524 - Substance Use Disorder Workforce Loan Repayment Act S.2456 - CARA 2.0 Act of 2018 H.R. 4284- INFO Act H.R. 5197, Alternatives to Opioids in the Emergency Room Department H.R. 5718, Perioperative Reduction of Opioids (PRO) Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5002, Ace Research Act H.R. 1783- Improving Veterans Access to Quality Care Act of 2017

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

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

S. 445/ H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R. 315 [P.L. No: 115-320] - Improving Access to Maternity Care Act S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R.3692 - Addiction Treatment Access Improvement Act of 2017 H.R. 6 [P.L. No: 115-271] - SUPPORT for Patients and Communities Act H.Res.1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 449 - Synthetic Drug Awareness Act of 2017 H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 Medicare Carrier Advisory Committees Reducing Regulatory Burdens H.R.6310 - Primary Care Enhancement Act of 2018 H.R.6317 - Primary Care Enhancement Act of 2018 H.R.6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018

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

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

S.445/H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R.315 [P.L. No: 115-320] - Improving Access to Maternity Care Act H.R.3692 - Addiction Treatment Access Improvement Act of 2017 S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 Alexander-Murray Bipartisan Health Care Stabilization Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Graham-Cassidy-Heller-Johnson Amendment in the nature of a substitute to H.R. 1628 - American Health Care Act of 2017 H.R. 1628 - American Health Care Act of 2017 Better Care Reconciliation Act Discussion Draft S. 222 - Obamacare Replacement Act H.R. 372 - Competitive Health Insurance Reform Act of 2017 S. 934 - FDA Reauthorization Act of 2017 S. 870 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 H.R. 449 - The Synthetic Drug Awareness Act of 2017 S. 191 - Patient Freedom Act of 2017 S. 403 - Health Savings Act of 2017 H.R. 1136 - FDA Deeming Authority Clarification Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 H.R. 6 [P.L. No: 115-271] - SUPPORT for Patients and Communities Act H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331/S.1732 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 H.Res 1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 6310/H.R. 6317 - Primary Care Enhancement Act of 2018 H.R. 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R. 6502 - Reducing Unnecessary Senior Hospitalizations Act of 2018 Medical Record Documentation Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic Medicare Carrier Advisory Committees Reducing Regulatory Burdens

Client expense: $206,455 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), SENATE, Veterans Affairs, Dept of (VA), White House Office

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

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

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $900,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,480,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---Transfer of Authority for National Strategic Stockpile ------S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---National Biodefense Strategy Biosimilars ---Access to Samples for Testing ---Coding ---Naming ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Patient-Focused Drug Development ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Drug Product Communications ---H.R. 1703: The Medical Products Communications Act of 2017 ---S. 2157: Drug-Price Transparency in Communications Act ---Direct to Consumer Advertising Disclosures ------H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------H.R. 6157: Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---S. 974/H.R. 2212: CREATES Act of 2017 ---H.R. 749: Lower Drug Costs Through Competition Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education

Client expense: $2,480,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Defense, Dept of (DOD), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $5,990,000 · 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), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

ASCE's Report Card for America's Infrastructure Tax Exempt Muni Bonds Private Activity Bonds H.R. 5002, Reinstate Advance Refunding Bonds Federal Highway Trust Fund

Client expense: $634,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Oceanic & Atmospheric Administration (NOAA), Natl Science Foundation (NSF), SENATE, Transportation, Dept of (DOT), U.S. Geological Survey (USGS)

Issues related to implementation of the 21st Century Cures Act (Public Law No: 114-255); in general H.R. 5311/S. 2456, the CARA 2.0 Act of 2018 H.R. 2556/S. 1016, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 1850, the Protecting Jessica Grubbs Legacy Act H.R. 3545, the Overdose Prevention and Patient Safety Act Docket ID: SAMHSA-4162-20, Confidentiality of Substance Use Disorder Patient Records Issues relating to the reauthorization of the Childrens Health Insurance Program H.R. 3192/S. 2253, the CHIP Mental Health Parity Act S. 774, the Trauma-Informed Care for Children and Families Act H.R. 4778/S. 2301, the Behavioral Health Coverage Transparency Act S. 2406/H.R. 5002, the Advancing Cutting-Edge (ACE) Research Act H.R. 5102/S. 2524, the Substance use Disorder Workforce Loan Repayment Act Issues relating to market stabilization for the Affordable Care Act Issues related to opioids. Issues related to gun violence and mental health, in general H.R. 2276/S. 2575, the Audiology Patient Choice Act H.R. 6, SUPPORT for Patients and Communities Act S. 2680, the Opioid Crisis Response Act H.R. 994, the Examining Opioid Treatment Infrastructure Act H.R. 1375, a bill to amend the Public Health Service Act to authorize the Secretary of Health of Human Services to award grants to States (or collaborations of States) to establish, expand, or maintain a comprehensive regional, State, or municipal system to provide training, education, consultation, and other resources to prescribers relating to patient pain, substance misuse, and substance abuse disorders, and for other purposes. S. 581/H.R. 5009, Jessie's Law H.R. 2077, theRestoring the Patient's Voice Act H.R. 2345, the National Suicide Hotline Improvement Act S. 1354, a bill to establish an Individual Market Reinsurance fund to provide funding for State individual market stabilization reinsurance programs. H.R. 3692, the Addiction Treatment Access Improvement Act H.R. 3931/S.1905, the Excellence in Mental Health and Addiction Treatment Expansion Act H.R. 4733/S. 2260, the Opioids and STOP Pain Initiative Act S. 2317, a bill to amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. H.R. 4903, Combating Opioid Misuse By Advancing Treatment (COMBAT) Act H.R. 5083, the Expanding Access to Evidence-Based Opioid Treatment for Seniors Act H.R. 5327, the Comprehensive Opioid Recovery Centers Act H.R. 5385/S. 2597, the Children's Hospital GME Support Reauthorization Act S. 2606, the Opioid ECHO Act H.R. 5795, the Overdose Prevention and Patient Safety Act H.R. 5483, the Special Registration for Telemedicine Clarification Act H.R. 6082, the Overdose Prevention and Patient Safety Act S.3337, the Mental Health Services for Students Act H.R.6597, the Mental Health Professionals Workforce Shortage Loan Repayment Act Issues relating to suicide prevention; in general Issues relating to the enforcement of mental health parity; in general

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), U.S. Immigration & Customs Enforcement (ICE), Veterans Affairs, Dept of (VA)

H.R. 1628 American Health Care Act of 2017 H.R. 1776 and S. 771 Improving Access to Affordable Prescription Drugs Act S. 2406 H.R. 5002 Advancing Cutting-Edge (ACE) Research Act S. 2456, H.R. 5311Comprehensive Addition and Recovery Act CARA 2.0 of 2018 S.2680 Opioid Crisis Response Act of 2018 H.R. 5002 ACE Research Act H.R. 5247 S. 204 Right to Try Act of 2018

Client expense: $63,807 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.445/H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R.315 - Improving Access to Maternity Care Act H.R.3692 - Addiction Treatment Access Improvement Act of 2017 S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 Alexander-Murray Bipartisan Health Care Stabilization Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Graham-Cassidy-Heller-Johnson Amendment in the nature of a substitute to H.R. 1628 - American Health Care Act of 2017 H.R. 1628 - American Health Care Act of 2017 Better Care Reconciliation Act Discussion Draft S. 222 - Obamacare Replacement Act H.R. 372 - Competitive Health Insurance Reform Act of 2017 S. 934 - FDA Reauthorization Act of 2017 S. 870 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 H.R. 449 - The Synthetic Drug Awareness Act of 2017 S. 191 - Patient Freedom Act of 2017 S. 403 - Health Savings Act of 2017 H.R. 1136 - FDA Deeming Authority Clarification Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331/S.1732 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 H.Res 1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 6310/H.R. 6317 - Primary Care Enhancement Act of 2018 H.R. 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medical Record Documentation Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic Medicare Carrier Advisory Committees Reducing Regulatory Burdens

Client expense: $167,141 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), SENATE, Veterans Affairs, Dept of (VA), White House Office

S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.3692, S.2317 - Addiction Treatment Access Improvement Act of 2017 HR6, SUPPORT for Patients and Communities Act H.R. 5102, S. 2524 - Substance Use Disorder Workforce Loan Repayment Act S.2456 - CARA 2.0 Act of 2018 H.R. 4284- INFO Act H.R. 6 - SUPPORT for Patients and Communities Act H.Res.1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 5197, Alternatives to Opioids in the Emergency Room Department H.R. 5718, Perioperative Reduction of Opioids (PRO) Act H.R. 5774, Combating Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5002, Ace Research Act H.R. 1783- Improving Veterans Access to Quality Care Act of 2017 Nursing Workforce Development; Chronic Pain management

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

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

* 445/ H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R. 315 - Improving Access to Maternity Care Act S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R.3692 - Addiction Treatment Access Improvement Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act H.Res.1099 - Providing for the concurrence by the House in the Senate amendment to H.R. 6, with an amendment H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 449 - Synthetic Drug Awareness Act of 2017 H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 Medicare Carrier Advisory Committees Reducing Regulatory Burdens H.R.6310 - Primary Care Enhancement Act of 2018 H.R.6317 - Primary Care Enhancement Act of 2018 H.R.6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018

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

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

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) To amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) To amend title XVIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. 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 post-approval study requirements for certain controlled substances, and for other purposes. 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 postpartum women while receiving inpatient treatment for a substance use disorder, and for other purposes. 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 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 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. HR 5261 Treatment, Education, and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professional are educated in substance abuse disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a given program or activity; encourage the funding of evidence-based interventions; and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These Comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery. Either directly or through coordination with other entities, Centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The U.S. government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show "meaningful use" of a certified Electronic Health Record (EHR). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can each receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending upon when they begin attesting to the program's requirements. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) To amend title XVIII of the Social Security Act to require e-prescribing for coverage under Part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) To amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare Part D for covered Part D drugs, and for other purposes. HR 5675 To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) This bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) To amend title XVIII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) Requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors From Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) To amend title XVIII of the Social Security Act to expand eligibility for medication therapy management programs established under Part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

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 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

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) to amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) to amend title VIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. HR 3921 HEALTHY KIDS Act Introduced October 3, 2017 by Michael Burgess (R-TX) to extend funding for the Childrens Health Insurance Program and for other purposes. HR 1148 FAST Act of 2017 Introduced February 16, 2017 by Morgan Griffith (R-VA) to amend title XVII of the Social Security Act to expand access to telehealth-eligible stroke services under the Medicare program. HR 3192 CHIP Mental Health Parity Act Introduced July 12, 2017 by Joseph Kennedy III (D-MA) 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 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 and Energy and Commerce Committee and the Ways and Means Committee. 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 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 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 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. 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. HR 5261 Treatment, Education and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professionals are educated in substance abuse disorder prevention, treatment and recovery through development, evaluation, and distribution of evidence based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a give program or activity; encourage the funding of evidence-based interventions and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data and dramatically improve the opportunities for individuals to establish and maintain ling-term recovery. Either directly or through coordination with other entities, centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The US government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show meaningful use of a certified Electronic Health Record (HER). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending on when they begin attesting to the programs requirements. HR 5685 Medicare Opioid Safety Education Act of 2018 Introduced May 7, 2018 by John Faso (R-NY) directs the Centers for Medicare and Medicaid Services (CMS) to compile education resources for beneficiaries regarding opioid us, pain management, and alternative pain management treatments and include these resources in the Medicare and You handbook. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) to amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) to amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. HR 5675 To amend title XVII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) this bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) to amend title XVII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors from Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) to amend title XVII of the Social Security Act to expand eligibility for medication therapy management programs established under part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Genetically Engineered (GE) Animals ---Labeling ---Efficient Science-Based Review of Biotech Products ---FDA Proposed Guidance on Gene Editing ---H.R. 5961/S.2476: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ------Amendment on GE Salmon Labeling ---The Animal Drug User Fee Reauthorization Act of 2018 ------Amendment on GE Salmon Labeling Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Review and Labeling of Food Derived from Biotechnology ---Implementation of Disclosure Law

Client expense: $2,520,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

340B Drug Discount Program ---Program Implementation & Oversight ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---H.R. 4710: 340B Pause Act ---H.R. 5598: 340B Optimization Act ---S. 2453: Ensuring the Value of the 340B Program Act Access to Medicines/World Health Organization Antibiotic & Diagnostic Tax Credit ---H.R. 1840: Reinvigorating Antibiotic and Diagnostic Innovation Biodefense Research, Development and Procurement Issues (Non-funding) ---Tropical Disease Priority Review Voucher (PRV) Program ---Implementation of Medical Countermeasures Innovation Act ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 ---Pandemic and All-Hazards Preparedness Act (PAHPA) Reauthorization Act of 2017 (Reps. Brooks/Eshoo Discussion Draft) ---S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) Biosimilars ---Access to Samples for Testing ---Interchangeability and Pharmacy Substitution ---S. 974/H.R. 2212: CREATES Act of 2017 Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Proposed Rule on Changes to Drug Labeling ---Innovation Incentives ---Patient-Focused Drug Development ---S.204 / H.R. 878: Right to Try Act of 2017 ---Prescription Drug User Fee Act (PDUFA) VI Implementation ---FDA Management & Financial Accountability ---FDA Hiring Flexibility ---Priority Review Voucher Program ---Regulatory Reform & Modernization ---Use of Real World Evidence Drug Importation ---S.469: Affordable and Safe Prescription Drug Importation Act Drug Manufacturing, Quality & Distribution ---Pharmacy Compounding & Oversight ---Drug Shortages ---Supply Chain Integrity and Traceability ---Counterfeiting Drug Pricing ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 ---S. 1369 / H.R. 2974: Stop Price Gouging Act ---S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act ---S. 771: Improving Access to Affordable Prescription Drugs Drug Product Communications Foreign Drug Data Protection Laws Funding for Antimicrobial Resistance Programs ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 3219: Department of Defense Appropriations Act for FY 2018 ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for FDA ---H.R. 5961/S.2976: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2019 Funding for National Institutes of Health ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---S.3158: Departments of Labor, HHS, Education, and Related Agencies Appropriations Act for FY 2019 Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---Incentives for Generic Entry ---S. 974/H.R. 2212: CREATES Act of 2017 Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations North American Free Trade Agreement (NAFTA) Renegotiation ---Pricing and Reimbursement Provisions ---IP Provisions Opioid Crisis ---NIH Research ---FDA Reforms ---Coverage and Reimbursement ---Transparency ---H.R. 5590: Opioid Addiction Action Plan Act ---H.R. 5002: Advancing Cutting Edge Research Act ---H.R. 5473: Better Pain Management Through Better Data Act ---H.R. 5806: 21st Century Tools for Pain Addiction Treatment ---H.R. 6: SUPPORT for Patients and Communities Act ---S.2665: Providing Clarity in Development of Pain Treatment ---S.2669: Advancing Innovation in Alternative Pain and Addiction Therapies Act ---S.2680: Opioid Crisis Response Act ---S.2769: HEAL Act Orphan Drug Issues ---Tax Credit Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6142/S. 2042: Reducing Drug Waste Act Trade and Foreign Drug Price Controls UN High Level Commission on Access to Medicines ---IP Proposals Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---H.R. 4993: Vaccine Access Improvement Act

Client expense: $2,520,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

ASCE's Report Card for America's Infrastructure Tax Exempt Muni Bonds Private Activity Bonds H.R. 5002, Reinstate Advance Refunding Bonds Federal Highway Trust Fund

Client expense: $63,400 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Oceanic & Atmospheric Administration (NOAA), Natl Science Foundation (NSF), SENATE, Transportation, Dept of (DOT), U.S. Geological Survey (USGS)

Issues related to implementation of the 21st Century Cures Act (Public Law No: 114-255); in general H.R. 5311/S. 2456, the CARA 2.0 Act of 2018 H.R. 2556/S. 1016, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 1850, the Protecting Jessica Grubbs Legacy Act H.R. 3545, the Overdose Prevention and Patient Safety Act Docket ID: SAMHSA-4162-20, Confidentiality of Substance Use Disorder Patient Records Issues relating to the reauthorization of the Childrens Health Insurance Program H.R. 3192/S. 2253, the CHIP Mental Health Parity Act S. 774, the Trauma-Informed Care for Children and Families ActH.R. 4778/S. 2301, the Behavioral Health Coverage Transparency Act S. 2406/H.R. 5002, the Advancing Cutting-Edge (ACE) Research Act H.R. 5102/S. 2524, the Substance use Disorder Workforce Loan Repayment Act Issues relating to market stabilization for the Affordable Care Act Issues related to opioids. Issues related to gun violence and mental health, in general H.R. 2276/S. 2575, the Audiology Patient Choice Act H.R. 6, SUPPORT for Patients and Communities Act S. 2680, the Opioid Crisis Response Act of 2018 H.R. 994, the Examining Opioid Treatment Infrastructure Act H.R. 1375, a bill to amend the Public Health Service Act to authorize the Secretary of Health of Human Services to award grants to States (or collaborations of States) to establish, expand, or maintain a comprehensive regional, State, or municipal system to provide training, education, consultation, and other resources to prescribers relating to patient pain, substance misuse, and substance abuse disorders, and for other purposes. S. 581/H.R. 5009, Jessie's Law H.R. 2077, theRestoring the Patient's Voice Act H.R. 2345, the National Suicide Hotline Improvement Act S. 1354, a bill to establish an Individual Market Reinsurance fund to provide funding for State individual market stabilization reinsurance programs. H.R. 3692, the Addiction Treatment Access Improvement Act H.R. 3931/S.1905, the Excellence in Mental Health and Addiction Treatment Expansion Act H.R. 4733/S. 2260, the Opioids and STOP Pain Initiative Act H.R. 4778/S. 2301, Behavioral Health Coverage Transparency Act S. 2317, a bill to amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. H.R. 4903, Combating Opioid Misuse By Advancing Treatment (COMBAT) Act H.R. 5083, the Expanding Access to Evidence-Based Opioid Treatment for Seniors Act H.R. 5327, the Comprehensive Opioid Recovery Centers Act H.R. 5385/S. 2597, the Children's Hospital GME Support Reauthorization Act S. 2606, the Opioid ECHO Act H.R. 5795, the Overdose Prevention and Patient Safety Act H.R. 5483, the Special Registration for Telemedicine Clarification Act H.R. 6082, the Overdose Prevention and Patient Safety Act

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

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Natl Institutes of Health (NIH), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), U.S. Immigration & Customs Enforcement (ICE), Veterans Affairs, Dept of (VA)

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Opioids shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $5,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 394, Restoring Access to Medication Act of 2017, all provisions S. 85, Restoring Access to Medication Act of 2017, all provisions S. 2456, CARA 2.0 Act of 2018, all provisions S. 2680, Opioid Crisis Response Act of 2018, all provisions S. 2535, Opioid Quota Reform Act, all provisions H.R. 6, Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, all provisions S. 3120, Helping to End Addiction and Lessen Substance Use Disorders Act of 2018, all provisions S. 2891, Fighting the Opioid Epidemic with Sunshine Act of 2018, all provisions S. 3042, Agriculture Improvement Act of 2018, provisions related to the SNAP Program H.R. 5818, Opioid Workforce Act of 2018, all provisions S. 2843, Opioid Workforce Act of 2018, all provisions H.R. 3692, Addiction Treatment Access Improvement Act of 2017, all provisions H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies (CONNECTIONS) Act of 2018, all provisions H.R. 5002, Advancing Cutting Edge (ACE) Research Act, all provisions S. 2406, Advancing Cutting Edge (ACE) Research Act, all provisions H.Amdt.627 to H.R. 2, provisions relating to unpasteurized milk or milk products H.R. 449, Synthetic Drug Awareness Act of 2018, all provisions H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act, all provisions H.R. 4284, Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018, all provisions H.R. 5041, Safe Disposal of Unused Medication Act, all provisions H.R. 5202, Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018, all provisions H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act of 2018, all provisions S. 2524, Substance Use Disorder Workforce Loan Repayment Act of 2018, all provisions H.R. 5176, Preventing Overdoses While in Emergency Rooms Act of 2018, all provisions H.R. 5197, Alternatives to Opioids (ALTO) in the Emergency Department Act, all provisions H.R. 5261, Treatment, Education, and Community Help (TEACH) to Combat Addiction Act of 2018, all provisions H.R. 5272, Reinforcing Evidence-Based Standards Under Law in Treating Substance Abuse (RESULTS) Act of 2018, all provisions H.R. 5327, Comprehensive Opioid Recovery Centers Act of 2018, all provisions H.R. 5329, Poison Center Network Enhancement Act of 2018, all provisions H.R. 5483, Special Registration for Telemedicine Clarification Act of 2018, all provisions H.R. 5580, Surveillance and Testing of Opioids to Prevent (STOP) Fentanyl Deaths Act of 2018, all provisions H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate (SOUND) Disposal and Packaging Act of 2018, all provisions H.R. 5353, Eliminating Opioid Related Infectious Diseases Act of 2018, all provisions H.R. 5796, Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018, all provisions H.R. 1375, Prescriber Support Act of 2017, all provisions H.R. 5788, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2018, all provisions H.R. 1057, Synthetics Trafficking and Overdose Prevention (STOP) Act of 2017, all provisions H.R. 6142, Reducing Drug Waste Act of 2018, all provisions H.R. 4909, Student, Teachers, and Officers Preventing (STOP) School Violence Act of 2018, all provisions H.R. 4477, Fix NICS Act of 2017, all provisions S. 2135, Fix NICS Act of 2017, all provisions H.R. 4240, Public Safety and Second Amendment Rights Protection Act of 2017, all provisions S. 2456, CARA 2.0 Act of 2018, all provisions S. 1803, Marijuana Effective Drug Studies Act of 2017, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions Affordable Care Act stability 42 CFR Part 2/Substance abuse confidentiality regulations Substance Use Disorder Prescription Drug Monitoring Program (PDMP) Federal prescription limits Health Savings Accounts - Prescription requirement for over-the-counter medications Sunshine Act Regulations - journal reprints and textbooks Drug pricing transparency Augmented Intelligence (AI) Laboratory testing oversight Laboratory Developed Tests Software as a medical device Drug compounding Breastfeeding Patient Matching Mortality Cybersecurity Transparency in regulatory science Regulatory burdens Gun violence research Bump stocks Physician Assisted Suicide AMA/Google Health Care Interoperability and Innovation Challenge Health insurance premiums Title X funding Virtual Diabetes Prevention Program (DPP)/Telehealth/remote patient monitoring Electronic prescribing of controlled substances Pharmacy Benefits Manager HHS Blueprint to lower drug prices

Client expense: $4,300,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), SENATE, Veterans Affairs, Dept of (VA), White House Office

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $800,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Medicare Advantage; CHIP Reform; Medicare Access & CHIP Reauthorization Act of 2015 (MACRA); Rate Notice and Call Letter; Medicaid; Opioids; Air Ambulance; Medicare Part D HR 2575 Introduced May 19, 2017 by Raul Ruiz (R-CA) To amend title XVIII of the Social Security Act to establish a system to educate individuals approaching Medicare eligibility, to simplify and modernize the eligibility enrollment process, and for other purposes. HR 3780 Air Ambulance Quality and Accountability Act Introduced September 14, 2017 by Richard Hudson (R-NC) To amend title XVIII of the Social Security Act to provide under the Medicare program for conditions of participation, reporting requirements, and a quality program with respect to air ambulance services. HR 3921 HEALTHY KIDS Act Introduced October 3, 2017 by Michael Burgess (R-TX) To extend funding for the Children's Health Insurance Program, and for other purposes. HR 1148 FAST Act of 2017 Introduced February 16, 2017 by Morgan Griffith (R-VA) To amend title XVIII of the Social Security Act to expand access to telehealth-eligible stroke services under the Medicare program. HR 3192 CHIP Mental Health Parity Act Introduced July 12, 2017 by Joseph Kennedy III (D-MA) 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 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. HR 5261 Treatment, Education, and Community Help to Combat Addiction Act of 2018 Introduced March 13, 2018 by Bill Johnson (R-OH) directs the Secretary of Health and Human Services (HHS) to designate regional Centers of Excellence to enhance and improve how health professional are educated in substance abuse disorder prevention, treatment, and recovery through development, evaluation, and distribution of evidence-based curricula for health profession schools. The bill authorizes $4 million annually for grants to those programs over the 2019-2023 period. HR 5272 To provide additional guidance to grantees seeking funding to treat or prevent mental health or substance use disorders. Introduced March 14, 2018 by Steve Stivers (R-OH) Requires the newly established National Mental Health and Substance Use Policy Laboratory to issue guidance to applicants for Substance Abuse and Mental Health Services Administration (SAMHSA) grants that support evidence-based practices. The guidance shall include how best to articulate the rationale for a given program or activity; encourage the funding of evidence-based interventions; and encourage the replication of promising or effective practices. HR 5327 Comprehensive Opioid Recovery Centers Act of 2018 Introduced March 19, 2018 by Brett Guthrie (R-KY) directs the Secretary of Health and Human Services (HHS) to award grants to at least 10 providers that offer treatment services for people with opioid use disorder. These Comprehensive Opioid Recovery Centers would serve as models for comprehensive treatment and recovery and would utilize the full range of Food and Drug Administration approved medications and evidence-based treatments, have strong linkages with the community, generate meaningful outcomes data, and dramatically improve the opportunities for individuals to establish and maintain long-term recovery. Either directly or through coordination with other entities, Centers must provide services including withdrawal management, counseling, recovery housing, community-based and peer recovery support services, job training and placement assistance, pharmacy and toxicology services, and a secure and confidential electronic health information system. HR 5353 Eliminating Opioid Related Infectious Diseases Act of 2018 Introduced March 20, 2018 by Leonard Lance (R-NJ) Authorizes the Centers for Disease Control (CDC) to undertake an injection drug-use associated infection elimination initiative and work with states to improve education, surveillance, and treatment of infections associated with injection drug use. HR 3331 To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology Introduced July 20, 2017 by Lynn Jenkins (R-KY) authorizes the Center for Medicare and Medicaid Innovation to test a program offering incentive payments to behavioral health providers that adopt and use certified electronic health record technology. The U.S. government introduced the Meaningful Use program as part of the 2009 Health Information Technology for Economic and Clinical Health (HITECH) Act, to encourage health care providers to show "meaningful use" of a certified Electronic Health Record (EHR). In doing so, eligible providers who do so receive incentive payments, but behavioral health providers were not included in the definition of eligible providers. Individual physicians and other eligible health care professionals can each receive up to $44,000 through the Medicare Meaningful Use program or up to $63,750 through the Medicaid Meaningful Use program, depending upon when they begin attesting to the program's requirements. HR 5685 Medicare Opioid Safety Education Act of 2018 Introduced May 7, 2018 by John Faso (R-NY) directs the Centers for Medicare and Medicaid Services (CMS) to compile education resources for beneficiaries regarding opioid use, pain management, and alternative pain management treatments, and include these resources in the Medicare and You handbook. HR 3528 Every Prescription Conveyed Securely Act Introduced July 28, 2017 by Katherine Clark (D-MA) To amend title XVIII of the Social Security Act to require e-prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances. HR 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Introduced January 18, 2018 by David Schweikert (R-AZ) To amend title XVIII of the Social Security Act to provide for electronic prior authorization under Medicare part D for covered part D drugs, and for other purposes. HR 5675 To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries Introduced May 3, 2018 by Gus Bilirakis (R-FL) This bill requires Medicare prescription drug plan (PDP) sponsors, for plan years beginning on or after January 1, 2021, to establish drug management programs for at-risk beneficiaries. Current law authorizes, but does not require, PDP sponsors to establish such programs. HR 5686 Medicare Clear Health Options in Care for Enrollees Act of 2018 Introduced May 7, 2018 by Erik Paulsen (R-MN) To amend title XVIII of the Social Security Act to require prescription drug plans under Medicare part D to include information on the adverse effects of opioid overutilization and of coverage of nonpharmacological therapies and nonopioid medications or devices used to treat pain. HR 5582 Abuse Deterrent Access Act of 2018 Introduced April 23, 2018 by Buddy Carter (R-GA) Requires the Secretary of the Department of Health and Human Services (HHS) to report to Congress on existing barriers to access to abuse-deterrent opioid formulations by Medicare Part C and D beneficiaries. HR 5684 Protecting Seniors From Opioid Abuse Act Introduced May 7, 2018 by Mike Kelly (R-PA) To amend title XVIII of the Social Security Act to expand eligibility for medication therapy management programs established under part D of the Medicare program to include certain individuals who are at risk for prescription drug abuse.

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

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

H.R. 1628 American Health Care Act of 2017 H.R. 1776 and S. 771 Improving Access to Affordable Prescription Drugs Act S. 2406 H.R. 5002 Advancing Cutting-Edge (ACE) Research Act S. 2456, H.R. 5311Comprehensive Addition and Recovery Act CARA 2.0 of 2018 S.2680 Opioid Crisis Response Act of 2018 H.R. 5002 ACE Research Act H.R. 5247 S. 204 Right to Try Act of 2018

Client expense: $13,899 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

1.S. 2317/H.R. 3692 - Addiction Treatment Access Improvement Act - amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. 2.H.R. 6 - SUPPORT for Patients and Communities Act - provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. 3.S. 2406/H.R. 5002 - Advancing Cutting Edge Research Act - expand the unique research initiatives authority of the National Institutes of Health 4.S. 2608 - Opioid Crisis Response Act - address the opioid crisis 5.H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act - provide for an opioid use disorder treatment demonstration program, and for other purposes 6.H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases. 7.H.R. 5800 - the Medicaid IMD ADDITIONAL INFO Act - require the Medicaid and CHIP Payment and Access Commission to conduct an exploratory study and report on requirements applicable to and practices of institutions for mental diseases under the Medicaid program. 8.H.R. 5483 - Special Registration for Telemedicine Clarification Act - impose a deadline for the promulgation of interim final regulations in accordance with section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) specifying the circumstances in which a special registration may be issued to a practitioner to engage in the practice of telemedicine, and for other purposes. 9.S. 2589/H.R. 5327 - Comprehensive Opioid Recovery Centers Act - amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers, and for other purposes 10.H.R. 5272 - a bill to ensure that programs and activities that are funded by a grant, cooperative agreement, loan, or loan guarantee from the Department of Health and Human Services, and whose purpose is to prevent or treat a mental health or substance use disorder, are evidence-based 11.H.R. 5261 - TEACH to Combat Addiction Act - amend the Public Health Service Act to provide for regional centers of excellence in substance use disorder education, and for other purposes 12.S. 2610/H.R. 5176 - Preventing Overdoses While in Emergency Rooms (POWER) Act - require the Secretary of Health and Human Services to provide coordinated care to patients who have experienced a non-fatal overdose after emergency room discharge, and for other purposes 13.S. 2524/H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act - amend the Public Health Service Act to authorize a loan repayment program for substance use disorder treatment employees, and for other purposes 14.H.R. 4005 - the Medicaid Reentry Act - promote State innovations to ease transitions to the community for individuals who are inmates of a public institution and eligible for medical assistance under the Medicaid program. 15.S. 2253/H.R. 3192 - the CHIP Mental Health Parity Act - 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 16.S. 3158 - FY2019 Labor-HHS Appropriations Act - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 17.House FY 2019 Labor, Health and Human Services, and Related Agencies - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 18.S. 2711, the Enhancing Access to Addiction Treatment Act - amend section 303 of the Controlled Substances Act to facilitate waivers of the separate registration requirement for physicians dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment 19.H.R. 5776 - Medicare and Opioid Safe Treatment Act - provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service 20.S. 2875 - Comprehensive Opioid Management and Bundled Addiction Treatment Act of 2018 - amend title XVIII of the Social Security Act to provide for Medicare coverage of certain services furnished by opioid treatment programs, and for other purposes 21.S. 2456/H.R. 5311 - CARA 2.0 Act - reauthorize and expand the Comprehensive Addiction and Recovery Act of 2016 22.S. 2700/ H.R. 5545 - Comprehensive Addiction Resources Emergency Act - provide emergency assistance to States, territories, Tribal nations, and local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families 23.S. 2843/H.R. 5818 - Opioid Workforce Act - amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis 24.S. 1169 - Medicaid Coverage for Addiction Recovery Expansion Act - amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes 25.Commented on draft legislation to amend title XXVII of the Public Health Service Act and titles XVIII and XIX of the Social Security Act to prohibit the imposition of prior authorization requirements with respect to a certain supply of a prescription drug used for the treatment of a substance use disorder, and for other purposes 26.S. 1276 - Cannabidiol Research Expansion Act - require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marihuana components

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

1.S. 2317/H.R. 3692 - Addiction Treatment Access Improvement Act - amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. 2.H.R. 6 - SUPPORT for Patients and Communities Act - provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. 3.S. 2406/H.R. 5002 - Advancing Cutting Edge Research Act - expand the unique research initiatives authority of the National Institutes of Health 4.S. 2608 - Opioid Crisis Response Act - address the opioid crisis 5.H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act - provide for an opioid use disorder treatment demonstration program, and for other purposes 6.H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases. 7.H.R. 5800 - the Medicaid IMD ADDITIONAL INFO Act - require the Medicaid and CHIP Payment and Access Commission to conduct an exploratory study and report on requirements applicable to and practices of institutions for mental diseases under the Medicaid program. 8.H.R. 5483 - Special Registration for Telemedicine Clarification Act - impose a deadline for the promulgation of interim final regulations in accordance with section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) specifying the circumstances in which a special registration may be issued to a practitioner to engage in the practice of telemedicine, and for other purposes. 9.S. 2589/H.R. 5327 - Comprehensive Opioid Recovery Centers Act - amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers, and for other purposes 10.H.R. 5272 - a bill to ensure that programs and activities that are funded by a grant, cooperative agreement, loan, or loan guarantee from the Department of Health and Human Services, and whose purpose is to prevent or treat a mental health or substance use disorder, are evidence-based 11.H.R. 5261 - TEACH to Combat Addiction Act - amend the Public Health Service Act to provide for regional centers of excellence in substance use disorder education, and for other purposes 12.S. 2610/H.R. 5176 - Preventing Overdoses While in Emergency Rooms (POWER) Act - require the Secretary of Health and Human Services to provide coordinated care to patients who have experienced a non-fatal overdose after emergency room discharge, and for other purposes 13.S. 2524/H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act - amend the Public Health Service Act to authorize a loan repayment program for substance use disorder treatment employees, and for other purposes 14.H.R. 4005 - the Medicaid Reentry Act - promote State innovations to ease transitions to the community for individuals who are inmates of a public institution and eligible for medical assistance under the Medicaid program. 15.S. 2253/H.R. 3192 - the CHIP Mental Health Parity Act - 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 16.S. 3158 - FY2019 Labor-HHS Appropriations Act - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 17.House FY 2019 Labor, Health and Human Services, and Related Agencies - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 18.S. 2711, the Enhancing Access to Addiction Treatment Act - amend section 303 of the Controlled Substances Act to facilitate waivers of the separate registration requirement for physicians dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment 19.H.R. 5776 - Medicare and Opioid Safe Treatment Act - provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service 20.S. 2875 - Comprehensive Opioid Management and Bundled Addiction Treatment Act of 2018 - amend title XVIII of the Social Security Act to provide for Medicare coverage of certain services furnished by opioid treatment programs, and for other purposes 21.S. 2456/H.R. 5311 - CARA 2.0 Act - reauthorize and expand the Comprehensive Addiction and Recovery Act of 2016 22.S. 2700/ H.R. 5545 - Comprehensive Addiction Resources Emergency Act - provide emergency assistance to States, territories, Tribal nations, and local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families 23.S. 2843/H.R. 5818 - Opioid Workforce Act - amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis 24.S. 1169 - Medicaid Coverage for Addiction Recovery Expansion Act - amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes 25.Commented on draft legislation to amend title XXVII of the Public Health Service Act and titles XVIII and XIX of the Social Security Act to prohibit the imposition of prior authorization requirements with respect to a certain supply of a prescription drug used for the treatment of a substance use disorder, and for other purposes 26.S. 1276 - Cannabidiol Research Expansion Act - require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marihuana components

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

1.S. 2317/H.R. 3692 - Addiction Treatment Access Improvement Act - amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. 2.H.R. 6 - SUPPORT for Patients and Communities Act - provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. 3.S. 2406/H.R. 5002 - Advancing Cutting Edge Research Act - expand the unique research initiatives authority of the National Institutes of Health 4.S. 2608 - Opioid Crisis Response Act - address the opioid crisis 5.H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act - provide for an opioid use disorder treatment demonstration program, and for other purposes 6.H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases. 7.H.R. 5800 - the Medicaid IMD ADDITIONAL INFO Act - require the Medicaid and CHIP Payment and Access Commission to conduct an exploratory study and report on requirements applicable to and practices of institutions for mental diseases under the Medicaid program. 8.H.R. 5483 - Special Registration for Telemedicine Clarification Act - impose a deadline for the promulgation of interim final regulations in accordance with section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) specifying the circumstances in which a special registration may be issued to a practitioner to engage in the practice of telemedicine, and for other purposes. 9.S. 2589/H.R. 5327 - Comprehensive Opioid Recovery Centers Act - amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers, and for other purposes 10.H.R. 5272 - a bill to ensure that programs and activities that are funded by a grant, cooperative agreement, loan, or loan guarantee from the Department of Health and Human Services, and whose purpose is to prevent or treat a mental health or substance use disorder, are evidence-based 11.H.R. 5261 - TEACH to Combat Addiction Act - amend the Public Health Service Act to provide for regional centers of excellence in substance use disorder education, and for other purposes 12.S. 2610/H.R. 5176 - Preventing Overdoses While in Emergency Rooms (POWER) Act - require the Secretary of Health and Human Services to provide coordinated care to patients who have experienced a non-fatal overdose after emergency room discharge, and for other purposes 13.S. 2524/H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act - amend the Public Health Service Act to authorize a loan repayment program for substance use disorder treatment employees, and for other purposes 14.H.R. 4005 - the Medicaid Reentry Act - promote State innovations to ease transitions to the community for individuals who are inmates of a public institution and eligible for medical assistance under the Medicaid program. 15.S. 2253/H.R. 3192 - the CHIP Mental Health Parity Act - 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 16.S. 3158 - FY2019 Labor-HHS Appropriations Act - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 17.House FY 2019 Labor, Health and Human Services, and Related Agencies - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 18.S. 2711, the Enhancing Access to Addiction Treatment Act - amend section 303 of the Controlled Substances Act to facilitate waivers of the separate registration requirement for physicians dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment 19.H.R. 5776 - Medicare and Opioid Safe Treatment Act - provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service 20.S. 2875 - Comprehensive Opioid Management and Bundled Addiction Treatment Act of 2018 - amend title XVIII of the Social Security Act to provide for Medicare coverage of certain services furnished by opioid treatment programs, and for other purposes 21.S. 2456/H.R. 5311 - CARA 2.0 Act - reauthorize and expand the Comprehensive Addiction and Recovery Act of 2016 22.S. 2700/ H.R. 5545 - Comprehensive Addiction Resources Emergency Act - provide emergency assistance to States, territories, Tribal nations, and local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families 23.S. 2843/H.R. 5818 - Opioid Workforce Act - amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis 24.S. 1169 - Medicaid Coverage for Addiction Recovery Expansion Act - amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes 25.Commented on draft legislation to amend title XXVII of the Public Health Service Act and titles XVIII and XIX of the Social Security Act to prohibit the imposition of prior authorization requirements with respect to a certain supply of a prescription drug used for the treatment of a substance use disorder, and for other purposes 26.S. 1276 - Cannabidiol Research Expansion Act - require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marihuana components

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

1.S. 2317/H.R. 3692 - Addiction Treatment Access Improvement Act - amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. 2.H.R. 6 - SUPPORT for Patients and Communities Act - provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. 3.S. 2406/H.R. 5002 - Advancing Cutting Edge Research Act - expand the unique research initiatives authority of the National Institutes of Health 4.S. 2608 - Opioid Crisis Response Act - address the opioid crisis 5.H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act - provide for an opioid use disorder treatment demonstration program, and for other purposes 6.H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases. 7.H.R. 5800 - the Medicaid IMD ADDITIONAL INFO Act - require the Medicaid and CHIP Payment and Access Commission to conduct an exploratory study and report on requirements applicable to and practices of institutions for mental diseases under the Medicaid program. 8.H.R. 5483 - Special Registration for Telemedicine Clarification Act - impose a deadline for the promulgation of interim final regulations in accordance with section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) specifying the circumstances in which a special registration may be issued to a practitioner to engage in the practice of telemedicine, and for other purposes. 9.S. 2589/H.R. 5327 - Comprehensive Opioid Recovery Centers Act - amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers, and for other purposes 10.H.R. 5272 - a bill to ensure that programs and activities that are funded by a grant, cooperative agreement, loan, or loan guarantee from the Department of Health and Human Services, and whose purpose is to prevent or treat a mental health or substance use disorder, are evidence-based 11.H.R. 5261 - TEACH to Combat Addiction Act - amend the Public Health Service Act to provide for regional centers of excellence in substance use disorder education, and for other purposes 12.S. 2610/H.R. 5176 - Preventing Overdoses While in Emergency Rooms (POWER) Act - require the Secretary of Health and Human Services to provide coordinated care to patients who have experienced a non-fatal overdose after emergency room discharge, and for other purposes 13.S. 2524/H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act - amend the Public Health Service Act to authorize a loan repayment program for substance use disorder treatment employees, and for other purposes 14.H.R. 4005 - the Medicaid Reentry Act - promote State innovations to ease transitions to the community for individuals who are inmates of a public institution and eligible for medical assistance under the Medicaid program. 15.S. 2253/H.R. 3192 - the CHIP Mental Health Parity Act - 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 16.S. 3158 - FY2019 Labor-HHS Appropriations Act - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 17.House FY 2019 Labor, Health and Human Services, and Related Agencies - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 18.S. 2711, the Enhancing Access to Addiction Treatment Act - amend section 303 of the Controlled Substances Act to facilitate waivers of the separate registration requirement for physicians dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment 19.H.R. 5776 - Medicare and Opioid Safe Treatment Act - provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service 20.S. 2875 - Comprehensive Opioid Management and Bundled Addiction Treatment Act of 2018 - amend title XVIII of the Social Security Act to provide for Medicare coverage of certain services furnished by opioid treatment programs, and for other purposes 21.S. 2456/H.R. 5311 - CARA 2.0 Act - reauthorize and expand the Comprehensive Addiction and Recovery Act of 2016 22.S. 2700/ H.R. 5545 - Comprehensive Addiction Resources Emergency Act - provide emergency assistance to States, territories, Tribal nations, and local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families 23.S. 2843/H.R. 5818 - Opioid Workforce Act - amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis 24.S. 1169 - Medicaid Coverage for Addiction Recovery Expansion Act - amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes 25.Commented on draft legislation to amend title XXVII of the Public Health Service Act and titles XVIII and XIX of the Social Security Act to prohibit the imposition of prior authorization requirements with respect to a certain supply of a prescription drug used for the treatment of a substance use disorder, and for other purposes 26.S. 1276 - Cannabidiol Research Expansion Act - require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marihuana components

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

1.S. 2317/H.R. 3692 - Addiction Treatment Access Improvement Act - amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. 2.H.R. 6 - SUPPORT for Patients and Communities Act - provide for opioid use disorder prevention, recovery, and treatment, and for other purposes. 3.S. 2406/H.R. 5002 - Advancing Cutting Edge Research Act - expand the unique research initiatives authority of the National Institutes of Health 4.S. 2608 - Opioid Crisis Response Act - address the opioid crisis 5.H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act - provide for an opioid use disorder treatment demonstration program, and for other purposes 6.H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases. 7.H.R. 5800 - the Medicaid IMD ADDITIONAL INFO Act - require the Medicaid and CHIP Payment and Access Commission to conduct an exploratory study and report on requirements applicable to and practices of institutions for mental diseases under the Medicaid program. 8.H.R. 5483 - Special Registration for Telemedicine Clarification Act - impose a deadline for the promulgation of interim final regulations in accordance with section 311(h) of the Controlled Substances Act (21 U.S.C. 831(h)) specifying the circumstances in which a special registration may be issued to a practitioner to engage in the practice of telemedicine, and for other purposes. 9.S. 2589/H.R. 5327 - Comprehensive Opioid Recovery Centers Act - amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers, and for other purposes 10.H.R. 5272 - a bill to ensure that programs and activities that are funded by a grant, cooperative agreement, loan, or loan guarantee from the Department of Health and Human Services, and whose purpose is to prevent or treat a mental health or substance use disorder, are evidence-based 11.H.R. 5261 - TEACH to Combat Addiction Act - amend the Public Health Service Act to provide for regional centers of excellence in substance use disorder education, and for other purposes 12.S. 2610/H.R. 5176 - Preventing Overdoses While in Emergency Rooms (POWER) Act - require the Secretary of Health and Human Services to provide coordinated care to patients who have experienced a non-fatal overdose after emergency room discharge, and for other purposes 13.S. 2524/H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act - amend the Public Health Service Act to authorize a loan repayment program for substance use disorder treatment employees, and for other purposes 14.H.R. 4005 - the Medicaid Reentry Act - promote State innovations to ease transitions to the community for individuals who are inmates of a public institution and eligible for medical assistance under the Medicaid program. 15.S. 2253/H.R. 3192 - the CHIP Mental Health Parity Act - 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 16.S. 3158 - FY2019 Labor-HHS Appropriations Act - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 17.House FY 2019 Labor, Health and Human Services, and Related Agencies - making appropriations for the Departments of Labor, Health and Human Services, and Education, and related agencies for the fiscal year ending September 30, 2019, and for other purposes 18.S. 2711, the Enhancing Access to Addiction Treatment Act - amend section 303 of the Controlled Substances Act to facilitate waivers of the separate registration requirement for physicians dispensing narcotic drugs to individuals for maintenance treatment or detoxification treatment 19.H.R. 5776 - Medicare and Opioid Safe Treatment Act - provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service 20.S. 2875 - Comprehensive Opioid Management and Bundled Addiction Treatment Act of 2018 - amend title XVIII of the Social Security Act to provide for Medicare coverage of certain services furnished by opioid treatment programs, and for other purposes 21.S. 2456/H.R. 5311 - CARA 2.0 Act - reauthorize and expand the Comprehensive Addiction and Recovery Act of 2016 22.S. 2700/ H.R. 5545 - Comprehensive Addiction Resources Emergency Act - provide emergency assistance to States, territories, Tribal nations, and local areas affected by the opioid epidemic and to make financial assistance available to States, territories, Tribal nations, local areas, and public or private nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families 23.S. 2843/H.R. 5818 - Opioid Workforce Act - amend title XVIII of the Social Security Act to provide for the distribution of additional residency positions to help combat the opioid crisis 24.S. 1169 - Medicaid Coverage for Addiction Recovery Expansion Act - amend title XIX of the Social Security Act to provide States with an option to provide medical assistance to individuals between the ages of 22 and 64 for inpatient services to treat substance use disorders at certain facilities, and for other purposes 25.Commented on draft legislation to amend title XXVII of the Public Health Service Act and titles XVIII and XIX of the Social Security Act to prohibit the imposition of prior authorization requirements with respect to a certain supply of a prescription drug used for the treatment of a substance use disorder, and for other purposes 26.S. 1276 - Cannabidiol Research Expansion Act - require the Attorney General to make a determination as to whether cannabidiol should be a controlled substance and listed in a schedule under the Controlled Substances Act and to expand research on the potential medical benefits of cannabidiol and other marihuana components

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA)

S.445/H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R.315 - Improving Access to Maternity Care Act H.R.3692 - Addiction Treatment Access Improvement Act of 2017 S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 Alexander-Murray Bipartisan Health Care Stabilization Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Graham-Cassidy-Heller-Johnson Amendment in the nature of a substitute to H.R. 1628 - American Health Care Act of 2017 H.R. 1628 - American Health Care Act of 2017 Better Care Reconciliation Act Discussion Draft S. 222 - Obamacare Replacement Act H.R. 372 - Competitive Health Insurance Reform Act of 2017 S. 934 - FDA Reauthorization Act of 2017 S. 870 - Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 H.R. 449 - The Synthetic Drug Awareness Act of 2017 S. 191 - Patient Freedom Act of 2017 S. 403 - Health Savings Act of 2017 H.R. 1136 - FDA Deeming Authority Clarification Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331/S.1732 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic Medicare Carrier Advisory Committees Reducing Regulatory Burdens

Client expense: $171,580 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Motor Carrier Safety Administration, HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), SENATE, Veterans Affairs, Dept of (VA), White House Office

S. 1276 Cannabidiol Research Expansion Act S. 1803 Marijuana Effective Drug Studies (MEDS) Act H.R. 5002 Advancing Cutting Edge Research Act H.R. 5520 VA Medicinal Cannabis Research Act of 2018 FY2019 Department of Defense Appropriations Bills - funding for psychological research FY2019 Commerce/Justice/Science Appropriations Bills - funding for psychological research FY2019 Department of Veterans Affairs Appropriations Bills - funding for psychological research Marijuana and Cannabidiol Research Expansion Act

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

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

S. 445/ H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R. 315 - Improving Access to Maternity Care Act S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 Alexander-Murray Bipartisan Health Care Stabilization Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R.3692 - Addiction Treatment Access Improvement Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 449 - Synthetic Drug Awareness Act of 2017 H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 Medicare Carrier Advisory Committees Reducing Regulatory Burdens

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

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

S. 445/ H.R.1825 - Home Health Care Planning Improvement Act of 2017 H.R.1617/S.3067 - Promoting Access to Diabetic Shoes Act S.1109/H.R.959 - Title VIII Nursing Workforce Reauthorization Act of 2017 H.R.1160 - ACO Assignment Improvement Act of 2017 H.R. 1155 - To amend title XVIII of the Social Security Act to allow physician assistants, nurse practitioners, and clinical nurse specialists to supervise cardiac, intensive cardiac, and pulmonary rehabilitation programs. S.1361 - Improving Access to Cardiac and Pulmonary Rehabilitation Act of 2017 S.783/H.R. 315 - Improving Access to Maternity Care Act S. 2317 - Addiction Treatment Access Improvement Act of 2018 S.2004 / H.R. 4501- Combating the Opioid Epidemic Act S. 2456/H.R. 5311 - CARA 2.0 Act of 2018 H.R. 3922 - CHAMPIONING HEALTHY KIDS Act S. 1827: KIDS Act of 2017 Alexander-Murray Bipartisan Health Care Stabilization Act of 2017 S.1835 - Lower Premiums Through Reinsurance Act of 2017 H.R. 1478 - Gun Violence Research Act Medicare Extenders Home Infusion Therapy Medication-Assisted Therapies (MATs) Opioid Abuse Epidemic S.2680 - Opioid Crisis Response Act of 2018 S. 2891 - Fighting the Opioid Epidemic with Sunshine Act of 2018 S.2524/H.R. 5102 - Substance Use Disorder Workforce Loan Repayment Act of 2018 H.R.3692 - Addiction Treatment Access Improvement Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act H.R. 5605 - Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 3331 - To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology H.R. 449 - Synthetic Drug Awareness Act of 2017 H.R. 5002/S.2406 - Advancing Cutting-Edge (ACE) Research Act H.R. 5796 - Responsible Education Achieves Care and Healthy Outcomes for Users Treatment Act H.R. 5798 - Opioid Screening and Chronic Pain Management Alternatives for Seniors Act S.3120 - Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 Medicare Carrier Advisory Committees Reducing Regulatory Burdens

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

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

H.R. 5002/S. 2406, ACE Research Act H.R. 1478, Gun Violence Research Act

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R.4297 - Protecting Seniors Through Immunization Act HR4993, Vaccine Access Improvement Act, Technical fix to efficiently add new vaccines to VICPHR4297/S2103, Protecting Seniors through Immunization Act, HR 1625 - Consolidated Appropriatons Act of 2018 - Part D Doughnut HoleHR 1625 - Consolidated Approriations Act of 2018 - Ryan White and ADAP FundingHR 1892 - Further Extension of Continuing Appropriations Act, 2018 - Part D Doughnut Hole HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 4710 - 340B PAUSE ActS 2312 - HELP Act340B Drug Discount ProgramMedicare Part D - Doughnut Hole; Non-Interference ClauseFY19 Appropriations - DoD - Oral HealthFY19 Appropriations - HHS - Ryan White Program/ADAPHR 394 - Restoring Access to Medication ActS 85 - Restoring Access to Medication Act of 2017HR 4618 - To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication. Medicaid - access for chronic care patients Prescription Drug PricingS469 - Affordable and Safe Prescription Drug Importation Act HR 1245 - Affordable and Safe Prescription Drug Importation Act Drug Importation HR 242 - Medicare Prescription Drug Price Negotiation Act of 2017Draft legislation on opioids - FDA packaging and disposal Draft legislation on opioids - Tableting and Encapsulating Machine Regulation Act of 2018 H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $1,110,000 · Firm income: Not reported

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

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $9,960,000 · 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), Office of Administration, Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE

ASCE's Report Card for America's Infrastructure Tax Exempt Muni Bonds Private Activity Bonds H.R. 5002, Reinstate Advance Refunding Bonds Federal Highway Trust Fund

Client expense: $326,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Education, Dept of, Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Labor, Dept of (DOL), Natl Institute of Standards & Technology (NIST), Natl Oceanic & Atmospheric Administration (NOAA), Natl Science Foundation (NSF), SENATE, Transportation, Dept of (DOT), U.S. Geological Survey (USGS)

H.R. 394, Restoring Access to Medication Act of 2017, all provisions S. 85, Restoring Access to Medication Act of 2017, all provisions H.R. 1625, Consolidated Appropriations Act, 2018, provisions relating to Fix NICS Act, Dickey Amendment H.R. 3545, Overdose Prevention and Patient Safety Act, all provisions H.R. 5009, Jessie's Law, all provisions H.R. 5311, Comprehensive Addiction and Recovery Act (CARA) 2.0 Act of 2018, all provisions S. 2456, Comprehensive Addiction and Recovery Act (CARA) 2.0 Act of 2018, all provisions H.R. 1375, Prescriber Support Act of 2017, all provisions S. 2135, Fix NICS Act of 2017, all provisions H.R. 4909, Student, Teachers, and Officers Preventing (STOP) School Violence Act of 2018, all provisions H.R. 5002, Advancing Cutting-Edge (ACE) Research Act, all provisions S. 2406, Advancing Cutting-Edge (ACE) Research Act, all provisions H.R. 878, Right to Try Act of 2017, all provisions H.R. 2368, Right to Try Act, all provisions H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, all provisions S. 204, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, all provisions H.R. 4191, HHS Cybersecurity Modernization Act, all provisions H.R. 4163, Cyber Shield Act of 2017, all provisions S. 2020, Cyber Shield Act of 2017, all provisions H.R. 4613, Ensuring Patient Access to Healthcare Records Act of 2017 H.R. 2063, Opioid Preventing Abuse through Continuing Education (Opioid PACE) Act of 2017, all provisions S. 1803, Marijuana Effective Drug Studies Act of 2017, all provisions H.R. 1318, Preventing Maternal Deaths Act of 2017, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R. 5219, Opioid Prescription Verification Act of 2018, all provisions 42 CFR/Privacy of substance abuse records Opioid Abuse Cost-sharing reduction payments and ACA stabilization Health Savings Accounts - Prescription requirement for over-the-counter medications Telemedicine Electronic Health Records (EHR) Electronic prescribing of controlled substances Prescription Drug Monitoring Programs (PDMPs) Interoperability of EHRs and PDMPs Prior authorization and medically assisted therapy Continuing Medical Education (CME) requirements for DEA licensure Gun Violence Prescription drug pricing/transparency/value/prior authorization burdens Provider Price Transparency Continuing Medical Education (CME) and opioid/pain management prescribing Cybersecurity Laboratory Developed Tests (LDTs) Conscience Rights/Delegation of Authority Title X Funding Regulatory burdens FDA oversight of digital health tools/modernization options In-office Drug Compounding Virtual Diabetes Prevention Program/Telehealth Blood pressure device validation/accuracy

Client expense: $6,590,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Veterans Affairs, Dept of (VA), White House Office

H.R. 1628 American Health Care Act of 2017 H.R. 1776 and S. 771 Improving Access to Affordable Prescription Drugs Act S. 2406 H.R. 5002 Advancing Cutting-Edge (ACE) Research Act S. 2456, H.R. 5311Comprehensive Addition and Recovery Act CARA 2.0 of 2018

Client expense: $45,257 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1628 American Health Care Act of 2017 H.R. 1776 and S. 771 Improving Access to Affordable Prescription Drugs Act S. 2406 H.R. 5002 Advancing Cutting-Edge (ACE) Research Act S. 2456, H.R. 5311Comprehensive Addition and Recovery Act CARA 2.0 of 2018

Client expense: $25,257 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE