Reducing Drug Waste Act of 2018

Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act H.R. 4710 Protecting Access for the Underserved and Safety-Net Entities H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act Issues related to Part D coverage gap, no specific bill

Client expense: $2,700,000 · Firm income: Not reported

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

Vista Grande Project; Energy and Water appropriations; Water Resources Development Act; Infrastructure package, EPA water infrastructure programs, WIFIA, FEMA pre-disaster mitigation; H.R.8, H.R.5895, S.2975, H.R.6142, S.3073. S.3021

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

Government targets: Army, Dept of (Corps of Engineers), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), SENATE

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Contact concerning FDA authority to manage drug shortages, regulation of pharmacy compounding, implementation of the Drug Quality and Security Act. Communication with Congress on compounding. Communicated with House and Senate offices on drug shortages. Communication with DEA on opioid shortage of generic injectables. Support for S. 974, Creating and Restoring Equal Access to Equivalent Samples Act of 2018, and H.R. 6142, Reducing Drug Waste Act of 2018.

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

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

Medicare Part B coversage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars 340B Protecting Access for the Underserved and Safety-Net Entities S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" H.R. 5598 "340B Optimization Act" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act H.R. 4710 to the name Protecting Access for the Underserved and Safety-Net Entities H.R. 6 -- Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act or the SUPPORT for Patients and Communities Act H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill)

Client expense: $2,660,000 · Firm income: Not reported

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 H.R. 6142 Reducing Drug Wastage Act of 2018 FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289)

Client expense: $2,660,000 · Firm income: Not reported

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications, S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

H.R. 1267, Personal Health Investment Today (PHIT) Act, all provisions H.R. 4240, Public Safety and Second Amendment Rights Protection Act of 2017, all provisions H.R. 6142, Reducing Drug Waste Act of 2018, all provisions H.R. 6301, Promoting High-Value Health Care Through Flexibility for High Deductible Health Plans Act of 2018, all provisions H.R. 6199, Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018, all provisions H.R. 6305, Bipartisan HSA Improvement Act of 2018, all provisions H.R. 6306, Health Care Security Act of 2018, all provisions H.R. 6313, Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018, all provisions H.R. 6314, Health Savings Act of 2018, all provisions H.R. 6317, Primary Care Enhancement Act of 2018, all provisions H.R. 6082, Overdose Prevention and Patient Safety 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. 2680, Opioid Crisis Response Act of 2018, all provisions S. 3120, Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018, provisions relating to human services H.R. 6733, Know the Cost Act of 2018, all provisions S. 2554, Patient Right to Know Drug Prices Act, all provisions S. 2020, Cyber Shield Act of 2017, all provisions 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. 1375, Prescriber Support Act of 2017, all provisions S. 1016, Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017, provisions relating to telehealth S. 2456, CARA 2.0 Act of 2018, all provisions H.R. 4825, Marijuana Effective Drug Studies (MEDS) Act of 2018, all provisions S. 1112, Maternal Health Accountability Act of 2017, all provisions Diagnostic Accuracy and Innovation Prescription Drug Pricing Affordable Care Act (ACA) risk-adjustment program 42 CFR Part 2/Substance abuse confidentiality regulations Software as a Medical Device (SaMD) SaMD Transparency Certificate-of-Need Reform Physician-Owned Hospitals Augmented Intelligence (AI) Cybersecurity ACA Navigator program funding cuts Electronic Health Records (EHR) EHR Vendor Reporting Program EHR Interoperability In-Office Compounding Opioids Consent2Share demonstration Prescription drug costs and pricing Substance use disorder Medical price transparency Administrative burdens and simplification Telehealth Laboratory developed tests (LDTs) Health Savings Accounts - Prescription requirement for over-the-counter medications Electronic prescribing of controlled substances Prescription Drug Monitoring Program (PDMP) Federal prescription limits Sunshine Act Regulation - Journal reprints and textbooks Direct-to-consumer (DTC) advertising - prescription drug price disclosure Biosimilar Regulations Generic Drug Regulations Pharmacy Benefit Managers (PBMs) Surprise billing

Vista Grande Project; Energy and Water appropriations; Water Resources Development Act; Infrastructure package, EPA water infrastructure programs, WIFIA, FEMA pre-disaster mitigation; HR8, HR5895, S.2975, HR6142, S.3073

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

Government targets: Army, Dept of (Corps of Engineers), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), SENATE

Contact concerning FDA authority to manage drug shortages, regulation of pharmacy compounding, implementation of the Drug Quality and Security Act. Communication with Congress on compounding. Communicated with House and Senate offices on drug shortages.Communication with DEA on opioid shortage of generic injectables. Support for S. 974, Creating and Restoring Equal Access to Equivalent Samples Act of 2018, and H.R. 6142, Reducing Drug Waste Act of 2018.

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

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

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. 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. 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. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program HR 4993 Vaccine Access Improvement Act HR 4297/S 2103 Protecting Seniors Through Immunization Act H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - To require improved packaging and disposal methods with respect to certain drugs H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste HR 6378/S 2852 Pandemic and All Hazards Preparedness Act reauthorization HR 6294 REVAMP Act 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. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1327: SITSA Act - Provisions related to controlled substances 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 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Risk Evaluation and Mitigation Strategy (REMS) 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 TRICARE pharmacy pilot program 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) Pandemic and All-Hazards Preparedness Act, provisions related to emerging infectious diseases and antimicrobial resistance. HR 6 - SUPPORT for Patients and Communities Act HR 5687 - SOUND Disposal and Packaging ActHR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 394/S 85 - Restoring Access to Medication Act of 2017 HR 6199 - To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses. HR 6157 - FY19 Defense Appropriations ActS 3159 - FY19 Defense Appropriations ActS 3158 - FY19 Labor-HHS-Education Appropriations ActHouse Draft - FY19 Labor-HHS-Education Appropriations ActPatient Access in Medicaid program340B Discount Drug ProgramHR 4710 - 340B PAUSE ActHR 5598 - 340B Optimization Act HR 5958 - Phair Pricing Act of 2018

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation 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

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

Biosimilars, no specific bill Prescription drug value issues, no specific bill S. 469 Affordable and Safe Prescription Drug Importation Act H.R. 1245 Affordable and Safe Prescription Drug Importation Act S.Con.Res.3 A concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2017 and setting forth the appropriate budgetary levels for fiscal years 2018-2026 (importation, non-interference) 340B Protecting Access for the Underserved and Safety-Net Entities (340B PAUSE Act). S. 2042 Reducing Drug Waste Act of 2017 H.R. 6142 Reducing Drug Wastage Act of 2018 FDA issues, no specific bill S.3158 Labor, Health and Human Services Appropriations Act (Senate Report 115-289)

Client expense: $2,290,000 · Firm income: Not reported

Medicare Part B (Average Sales Price) Medicare Part D issues Coding and reimbursement for oncology drugs/biologics/biosimilars 340B Protecting Access for the Underserved and Safety-Net Entities S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" H.R. 5598 "340B Optimization Act" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act

Client expense: $2,290,000 · Firm income: Not reported

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)

Vista Grande Project; Energy and Water appropriations; Water Resources Development Act; Infrastructure package, EPA water infrastructure programs, WIFIA, FEMA pre-disaster mitigation; HR8, HR5895, S.2975, HR6142, S.3073

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

Government targets: Army, Dept of (Corps of Engineers), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), SENATE

H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems 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. 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. 5353; Leonard Lance, Eliminating Opioid Infectious Diseases 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 - To require improved packaging and disposal methods with respect to certain drugs H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program 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. 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 pri S. 2312: HELP Act - Provisions related to 340B progr S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B prog S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding 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 Cancer drug vial size policy issue Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

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

S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; Proposals related to drug pricing; S. 1347, RxCAP Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; H.R. 5867, H.R. 6142, Reducing Drug Waste Act of 2018; Discussions related to mental health/depression in the opioid epidemic;

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

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - information on drug prices S. 2554, Patient Right to Know Drug Prices Act (Collins) - information on drug prices H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues relating to opioids; issues relating to prescription drug price blueprint; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Vista Grande Project; Energy and Water appropriations; Water Resources Development Act; Infrastructure package, EPA water infrastructure programs, WIFIA, FEMA pre-disaster mitigation; HR8, HR5895, S.2975, HR6142, S.3073

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

Government targets: Army, Dept of (Corps of Engineers), Federal Emergency Management Agency (FEMA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Interior, Dept of (DOI), SENATE