CREATES Act of 2017

H.R. 2051: "FAST Generics Act of 2017", 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, issues pertaining to drug pricing. S. 974, H.R. 2212: "CREATES Act of 2017", regarding all provisions. H.R. 3976: "Access to Marketplace Insurance Act", issues pertaining to Third Party Payment Premiums (TPPs). S. 2680, H.R. 6: "The Opioid Crisis Response Act of 2018", regarding all provisions. S. 3042, H.R. 2: "Agriculture Improvement Act of 2018", issues pertaining to federal funding for AHPs. H.R. 302, FAA Reauthorization Act of 2018, issues pertaining to air ambulance pricing transparency. H.R. 6294: "REVAMP Act" - To amend the Federal Food, Drug and Cosmetic Act to encourage the development of priority antimicrobial products through the award of transferable exclusivity extension period, regarding all provisions. H.R. 6733: "Know the Cost Act" - To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit group health plans, health insurance issuers, prescription drug plan sponsors and Medicare Advantage organizations from limiting certain information on drug prices, regarding all provisions. Issues pertaining to the Affordable Care Act; Annual Appropriations; Reinsurance; Cost Sharing Reductions (CSRs); Individual Market; Short Term Limited Duration Plans; Part D Donut Hole fix; Free standing ERs; ESRD coverage by private health plans; Risk adjustment.

Client expense: $1,280,000 · Firm income: Not reported

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

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.

Client expense: $1,550,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

S 3702/HR 7223 - Tax legislation, provisions regarding generic drugs S 3738/HR 7251 - Patent legislation regarding inter partes review HR 302 - FAA Re-authorization (provisions related to air ambulance services HR 7217 - IMPROVE Act Blueprint on Drug Pricing State Reinsurance Program H.R. 6 - The Support for Patients and Communities Act S 1835 - Lower Premiums through Reinsurance Act of 2017. Collins (R-ME) HR 3545 - Overdose Prevention and Patient Safety Act. Murphy (R-PA) S 1850 - Protecting Jessica Grubbs Legacy Act. Manchin (D-WV) HR 4200 & S 2052 - To provide for temporary funding for health insurance cost-sharing reduction payments and provide targeted tax relief, and for other purposes. HR 2212 & S 974 - Creating and Restoring Equal Access To Equivalent Samples Act of 2017: A bill 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. Marino (R-PA) & Leahy (D-VT) S 1354 - Individual Health Insurance Marketplace Improvement Act: A bill to establish an individual market reinsurance fund to provide funding for state individual market stabilization reinsurance programs. Carper (D-DE) S 1859 - Healthcare Tax Relief Act: A bill to extend the moratorium on the annual fee on health insurance providers. Gardner (R-CO) H.R. 1215 - Protecting Access to Care Act of 2017: To improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. King (R-IA) H.R.1101 - Small Business Health Fairness Act of 2017: 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. Johnson (R-TX). S. 974 and H.R. 2212 - Creates Act of 2017: 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. Leahy (D-VT) & Marino (R-PA). HR 173 and S 40 - Middle Class Health Benefits Tax Repeal Act of 2017: To amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Kelly (R-PA) & Heller (R-NV). HR 708 - State Age Rating Flexibility Act of 2017: To amend title XXVII of the Public Health Service Act to change the permissible age variation in health insurance premium rates. Buschon (R-IN). HR 710 -Health Coverage State Flexibility Act of 2017: To amend the Patient Protection and Affordable Care Act to better align the grace period required for non-payment of premiums before discontinuing coverage under qualified health plans with such grace periods provided for under State law. Flores (R-TX). HR 749 - Lower Drug Costs through Competition Act: To increase competition in the pharmaceutical industry. Schrader (D-OR) H.R.1121 - Pre-existing Conditions Protection Act of 2017: To amend the Public Health Service Act to prohibit application of pre-existing condition exclusions and to guarantee availability of health insurance coverage in the individual and group market, contingent on the enactment of legislation repealing the Patient Protection and Affordable Care Act, and for other purposes. Walden (R-OR). HR 1175 and S 403 - Health Savings Act of 2017: To amend the Internal Revenue Code of 1986 to improve access to health care through expanded health savings accounts, and for other purposes. Paulsen (R-MN) & Hatch (R-UT). HR 1304 - Self-Insurance Protection Act: To amend the Employee Retirement Income Security Act of 1974, the Public Health Service Act, and the Internal Revenue Code of 1986 to exclude from the definition of health insurance coverage certain medical stop-loss insurance obtained by certain plan sponsors of group health plans. Roe (R-TN) HR 1776 & S 771 Improving Access To Affordable Prescription Drugs Act: To improve access to affordable prescription drugs. Schakowsky (D-IL) & Franken (D-MN) HR 2051 - 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. McKinley (R-WV) S 191 - Patient Freedom Act of 2017: To improve patient choice by allowing States to adopt market based alternatives to the Affordable Care Act that increase access to affordable health insurance and reduce costs while ensuring important consumer protections and improving patient care. Cassidy (R-LA) S 637 - Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017: To amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers. Wyden (D-OR) HR - 6082 Overdose Prevention and Patient Safety Act S 2554 Patient Right to Know Drug Prices Act

Client expense: $1,190,000 · Firm income: Not reported

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

S. 974, HR 2212 The Creates Act, increasing access to generic pharmaceuticals,

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

Government targets: Office of the Vice President of the United States, White House Office

S. 974, HR 2212 The Creates Act, increasing access to generic pharmaceuticals,

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

Government targets: Office of the Vice President of the United States, White House Office

Affordable Care Act; Health Care Reform; Reinsurance; Cost Sharing Reduction Subsidies; Drug Pricing; Individual Market Reform; Market Stabilization; Association Health Plans; Waivers; Short-Term Limited Duration Policies; issues related to delivery system and payment reforms; Part 2 substance use disorder regulation; HSAs; Risk Adjustment; Air Ambulance;Telemedicine HR. 6 Support for Patients and Communities Act of 2018 (Walden) HR. 6082 - Overdose Prevention and Patient Safety Act (Mullin) - 42 CFR Part 2 HR 2051 - FAST Generics Act - Amend the Food, Drug and Cosmetic Act to ensure that eligible product developers have access to approved drugs and licensed biological products HR 2212 CREATES Act - Promote competition in the market for drugs and biological products by facilitating timely entry of low-cost generic and biosimilar versions of those drugs and biological products. HR 695 - Further Additional Appropriations Act of 2019 - monitoring for potential inclusion of policies related to 42 CFR Part 2

Client expense: $140,000 · Firm income: Not reported

Government targets: Federal Communications Commission (FCC), HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

Client expense: $611,446 · Firm income: Not reported

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

CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.

Client expense: $83,374 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.

Client expense: $83,374 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CREATES Act (S.974/H.R.2212) - addresses REMS and market entry issues. Patent settlements legislation USMCA - regarding IP standards in USMCA. IPR - regarding PTO authority to administrative review of patents.

Client expense: $83,374 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues.

Client expense: $83,374 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CREATES Act (S.974/H.R.2212) - Addresses REMS and market entry issues. PACED Act (S.2514) - Restores PTO's authority to review patents despite assertion of sovereign immunity. Patent settlements legislation.

Client expense: $83,374 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Short-Term, Limited-Duration Insurance Proposed Rule H.J. Res. 125 Continuing Appropriations Act H.R. 2212/S. 974 Creating and Restoring Equal Access to Equivalent Samples(CREATES) Act H.R. 4618 To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R.4894 Harmful Tax Prevention Act Issues related to Medicare Part D Issues related to Drug Pricing Issues related to Short: Term, Limited: Duration Insurance Proposed Rule CMS-5528 - Issues related to International Pricing Index

Client expense: $100,000 · 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), Homeland Security, Dept of (DHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of

Issues related to the implementation of the Generic Drug User Fee Agreement; issues related to drug pricing; Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017; and S. 124, Preserve Access to Affordable Generics Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems 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. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal 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. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization 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. 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. 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 -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program 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 S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues 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 Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions 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: $920,000 · Firm income: Not reported

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

Support H.R. 304/S. 916, The Protecting Patient Access to Emergency Medications Act of 2017, a bill to amend the Controlled Substances Act with regard to the provision of emergency medical services and discussed companion legislation with the Senate; Support H.R. 372, The Competitive Health Insurance Reform Act of 2017, a bill to repeal McCarran-Ferguson with respect to the business of health insurance; Discussed with members of congress working on legislation that maintains coverage and improves Americas health care system through patient-centered care; Oppose HR 1156/ S 1133 , Patient Access to Higher Quality Health Care Act of 2017, a bill to repeal changes made by health care reform laws to the Medicare exception to the prohibition on certain physician referrals for hospitals; Support HR 1215, Protecting Access to Care Act, a bill to improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system; Urged CMS to release guidance pertaining to hospital co-location arrangements and to provide flexibility in the agencys co-location policies; Support HR 2141/ S 898, the Conrad State 30 and Physician Access Act of 2017, a bill that would reauthorize the Conrad State 30 Program and make other changes to improve patient access to care; Support S.781/ HR 1876. Good Samaritan Health Professional Act of 2017, a bill to amend the Public Health Service Act to limit the liability of health care professionals who volunteer to provide health care services in response to a disaster; Support HR 2212/ S 974Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2017, a bill 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; Meet with HRSA Administrator and senior staff on 340B drug pricing program; Discussed marketplace stabilization solutions with Hill staff; Support and Recommend changes to HR 1253, Mental Health and Substance Abuse Treatment Accessibility Act of 2017 a bill to authorize the Secretary of Health and Human Services to make loans and loan guarantees for constructing or renovating, or planning construction or renovation of, qualified psychiatric and substance abuse treatment facilities, and for other purposes: advocated for changes to clarify/expand the entities that can be loan applicants/recipients; Urged the Administration to suspend the faulty star ratings from the Hospital Compare website; Eliminate barriers to care with the creation of an Anti-Kickback safe harbor for clinical integration arrangements that establishes the basic accountabilities for the use of incentive payment or shared savings programs among hospitals, physicians and other providers, along with a safe-harbor for assistance to patients that would protect providers from financial penalties under the Civil Monetary Penalties (CMPs) for providing an inducement to a patient; Advocated for changes including: eliminating geographic and setting locations requirements so patients outside of rural areas can benefit from telehealth; expanding the types of technology that can be used, including remote monitoring; and covering all services that are safe to provide, rather than a small list of approved services; Submit Statement Stabilizing Premiums and Helping Individuals in the Individual Insurance Market for 2018: Health Care Stakeholders about the importance of stabilizing the Health Insurance Marketplaces for 2018 and beyond; We urged Congress to pass legislation to fund the ACA cost-sharing reductions; Urged Senators to oppose the Graham-Cassidy proposal being considered in the Senate because this proposal would make significant changes to health care coverage and health care financing; Review of H.R. 3528, Every Prescription Conveyed Securely Act, a bill 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; Discussions with Congress on prescription drug monitoring programs, the dispensing of controlled substances, and clinical workflow; Discussions with Congress on draft legislation related to prescription drug monitoring programs; Urged Congress to consider advancing solutions aimed at making our health care system stronger, protecting access and coverage, and exploring new delivery system reforms that have the potential to make care both more affordable and safer; Review of The Combating the Opioid Epidemic Act, a bill to provide funding to combat the opioid epidemic; Discussions with the White House/Office of National Drug Control Policy about the opioid epidemic, including concerns about regulations that prohibit the sharing of substance use disorder records among health care providers; Support H.R. 4392 a bill to prevent cuts to the 340B drug savings program, which would provide relief from deep cuts to payments to hospitals participating in the 340B program; Letter to congress outlining AHA opposition to a potential policy that would cut payments to hospitals treating hospice patients; Oppose H.R. 4710, 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act, a bill to amend the Public Health Service Act to establish a moratorium on the registration of certain new 340B hospitals and associated site; Sent comments to the Energy and Commerce Subcommittee on Oversight and Investigations for its hearing on Examining the Impact of Health Care Consolidation.; Letter sent to the Energy & Commerce Subcommittee for its hearing on, "Combating the Opioid Crisis: Helping Communities Balance Enforcement and Patient Safety"; Letter submitted to the Ways and Means Committee on policy recommendations to address the opioid epidemic; Sent letter to discuss the current state of health care costs, and efforts to increase transparency in the pricing of health care services and the quality of care; Addressed our concerns with the MedPAC Commissions draft recommendation to substantially reduce payments for off-campus stand-alone emergency departments (EDs) that are within 6 miles of an on-campus hospital ED; Support HR 4776, Hospital Preparedness Reauthorization Act of 2018, a bill to amend the Public Health Service Act to reauthorize a program of partnerships for State and regional hospital preparedness to improve surge capacity and would increase the level of authorized funding for the Hospital Preparedness Program to $515 million; Submitted statement to the Senate HELP Committee on the Hearing on How to Reduce Health Care Costs: Understanding the Cost of Health Care in America; Submitted a Statement for the HELP hearing on Effective Administration of the 340B Drug Pricing Program; Support certain provisions in Helping to End Addiction and Lesson (HEAL) Substance Use Disorders Act of 2018; Support HR 6071, Stretching Entity Resources for Vulnerable Communities Act or the SERV Communities Act, A bill to amend the Public Health Service Act to clarify the intent of the 340B program and provide for enhanced 340B program integrity; Support S 2597Childrens Hospital GME Support Reauthorization Act of 2018, A bill to amend the Public Health Service Act to reauthorize the program of payments to children's hospitals that operate graduate medical education programs; Support HR 3545, Overdose Prevention and Patient Safety ActA bill to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records; Support S 2516, Alternatives to Opioids (ALTO) in the Emergency Department ActA bill to direct the Secretary of Health and Human Services to conduct a demonstration program to test alternative pain management protocols to limit the use of opioids in emergency departments; Support HR 5176/ S 2610, Preventing Overdoses While in Emergency Rooms Act of 2018 A bill to 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; Submit statement to the Ways and Means Subcommittee on Health on the hearing Identifying Innovative Practices and Technology in Health Care; Support S 1845 Lead-Safe Housing for Kids Act" To amend the Lead-Based Paint Poisoning Prevention Act to provide for additional procedures for families with children under the age of 6; Submitted statement to the Energy & Commerce Health Subcommittee for the hearing "Improving the Coordination and Quality of Substance Use Disorder Treatment." The statement focuses on 42 CFR Part 2; Comments to HELP Committee's discussion draft of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; The current Pandemic and All-Hazards Preparedness Act (PAHPA) will sunset on October 1, 2018 so this is "must-do" legislation; Support S 2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI), A bill to reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act; Supports S. 2372, VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (VA MISSION Act of 2018).A bill to establish a permanent community care program for veterans, to establish a commission for the purpose of making recommendations regarding the modernization or realignment of facilities of the Veterans Health Administration, to improve construction of the Department of Veterans Affairs, to make certain improvements in the laws administered by the Secretary of Veterans Affairs relating to the home loan program of the Department of Veterans Affairs,Submitted a statement to the Ways and Means Committee hearing on "Lowering Costs and Expanding Access to Health Care through Consumer-Directed Health Plans;" Submitted a statement to the Senate HELP Subcommittee on "Primary Health and Retirement Security on Health Care in Rural America: Examining Experiences and Costs"; Submitted a statement to the Senate HELP Committee on "Reducing Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients"; Submitted comments on the consumer-directed health plan legislation to the Committee on Ways & Means; Submitted a statement to the Energy and Commerce Subcommittee on Health on "Opportunities to Improve the 340B Drug Pricing Program"; Discussions about maternal health issues sent by the majority oversight and health subcommittee chairs; Discussions about the Megan Rondini Act; Surprise billing letter to congressional and committee leadership and discussions with members on the same issue; Letter on short-term limited duration plan rule; Meeting with Committee to discuss clarification of Anti-Kickback Statute provisions in the SUPPORT Act.

Client expense: $5,460,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA), White House Office

Monitor implementation of the 340B Prescription Drug Discount Program; legislative issues related to access to samples of prescription drugs, including S.974/H.R.2212 - the CREATES Act of 2017s.

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

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

H.R. 2051, "FAST Generics Act of 2017", provisions regarding REMS. H.R. 1409, "Cancer Drug Parity Act of 2017", regarding all provisions. H.R. 2077, "Restoring the Patient's Voice Act of 2017", Step Therapy / Fail First. S. 974/ H.R. 2212, "CREATES Act of 2017", provisions regarding REMS. Issues relating to Cancer Drug Coverage Parity. Issues relating to Step Therapy / Fail First. Issues relating to Medicare Part D / Part B. Issues relating to Reimbursement for and patient access to Chimeric Antigen Receptor (CAR) T-cell therapies.

Client expense: $400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to generic drugs, drug pricing, S. 974 - CREATES Act of 2017, H.R.2212 - CREATES Act of 2017, Hatch Waxman Integrity Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA) of 2018"; issues related to PAHPA reauthorization; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"

Client expense: $790,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE

CREATES Act HR 2212 / S 974

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

CREATES Act HR 2212 / S 974 Issues relating to the Patent Trial and Appeals Board S. 1948 (patents and tribal sovereign immunity) Issues relating to patents as affecting drug pricing

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO), SENATE

S. 974- CREATES Act of 2017, H.R.2212 - CREATES Act of 2017, Issues relating to biodefense

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Drug pricing issues, access to generic medicines, Medicare Part D program and generic drugs Risk Evaluation and Mitigation Strategies (REMS), H.R. 2051 - FAST Generics Act of 2017, S.974, H.R. 2212 - CREATES Act of 2017 Biologics Price Competition and Innovation Act (BPCIA) transition provisions affecting Insulins, complex generics Medicare reimbursement for biosimilars, Pass through payments for biosimilars

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

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, White House Office

H.R. 2212 & S. 974-The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act; HHS Blueprint to lower drug prices and reduce out-of-pocket costs.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to barriers to generic drug and biosimilar market entry including pay-for-delay and REMS. S. 124, The Preserve Access to Affordable Generics Act of 2017 S.771/H.R. 1776, The Improving Access to Affordable Prescription Drugs Act of 2017 H.R. 2051, The Fair Access for Safe and Timely Generics Act of 2017 S. 974/H.R. 2212, The Creating and Restoring Equal Access to Equivalent Samples Act of 2017

Client expense: $1,993,000 · Firm income: Not reported

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

H.R. 2212 & S. 974-The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Policy and oversight related to the generic pharmaceutical industry H.R.2212/S. 974 - CREATES Act of 2017 H.R. 7251/S.3738 - Hatch-Waxman Integrity Act of 2018 H.R.6294 - REVAMP Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

ACA implementation (exchange operations and functionality, risk mitigation programs, risk adjustment) ACA reform (reconciliation, individual mandate, cost sharing reduction subsidies, reinsurance transitional policies) The Bipartisan Budget Act of 2018 (H.R. 1892) Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 (S. 974 and H.R. 2212) Overdose Prevention and Patient Safety Act (H.R. 3545 and H.R. 6082) Jessies Law (H.R. 5009) Mental health and substance use (42 CFR Part 2) Individual market and exchange stabilization Association health plans Short Term Limited Duration Plans Out of network billing (FAA Reauthorization Act of 2018, H.R. 302) ACA third party payments Telehealth Price of prescription drugs Opioid addiction issues and response (prescription drug monitoring programs) Prior authorization SUPPORT for Patients and Communities Act (H.R. 6) Veterans health care Task Force on the Impact of Affordable Housing Crisis Act of 2018 (S. 3231) Readiness for Elders and Americans with Disabilities Inclusion (READI) for Disaster Act (S. 3679)

Client expense: $1,840,000 · Firm income: Not reported

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

ACA implementation (exchange operations and functionality, risk mitigation programs, risk adjustment) ACA reform (reconciliation, individual mandate, cost sharing reduction subsidies, reinsurance transitional policies) The Bipartisan Budget Act of 2018 (H.R. 1892) Creating and Restoring Equal Access To Equivalent Samples (CREATES) Act of 2017 (S. 974 and H.R. 2212) Overdose Prevention and Patient Safety Act (H.R. 3545 and H.R. 6082) Jessies Law (H.R. 5009) Mental health and substance use (42 CFR Part 2) Individual market and exchange stabilization Association health plans Short Term Limited Duration Plans Out of network billing (FAA Reauthorization Act of 2018, H.R. 302) ACA third party payments Telehealth Price of prescription drugs Opioid addiction issues and response (prescription drug monitoring programs) Prior authorization SUPPORT for Patients and Communities Act (H.R. 6) Veterans health care Task Force on the Impact of Affordable Housing Crisis Act of 2018 (S. 3231) Readiness for Elders and Americans with Disabilities Inclusion (READI) for Disaster Act (S. 3679)

Client expense: $1,840,000 · Firm income: Not reported

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

- Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212)

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

Government targets: HOUSE OF REPRESENTATIVES, 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. 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. 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. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal 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. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing 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. 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. 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 S. 3775: Affordable Drug Manufacturing Act of 2018 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 Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions 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: $6,030,000 · 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, U.S. Trade Representative (USTR)

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 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 ---H.R. 6378/S.2852: Pandemic and All-Hazards Preparedness and Innovation Act (PAHPAIA) ---H.R. 7328: Pandemic and All-Hazards Preparedness and Innovation Act of 2018 ---National Biodefense Strategy ---Gene Editing 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 ---S.771: Improving Access to Affordable Prescription Drugs ---General 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 Funding for Antimicrobial Resistance Programs ---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 ---FY 2020 Labor, HHS, Education Appropriations (Discussion Draft House/Senate) 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 ---Incentives for Generic Drug Entry ---H.R. 297: Increasing Competition in Pharmaceuticals Act Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculations The United States-Mexico-Canada Agreement ---Pricing and Reimbursement Provisions ---IP Provisions ---Regulatory Harmonization US-UK Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-EU Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization US-Japan Trade Agreement ---IP Provisions ---Pricing and Reimbursement Provisions ---Regulatory Harmonization 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 Vaccines and Infectious Diseases ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program ---Vaccine Safety ---Adult Immunization Education ---Vaccine Quality Measure Diagnostic and Personalized Medicine Regulation and Oversight Precision Medicine Initiative

Client expense: $2,500,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), 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), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Issued relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); and the Ensuring the Value of the 340B Program Act (S. 2453). Biodefense research, development and procurement issues; Pandemic All Hazards Preparedness Act (PAHPA) reauthorization; pandemic flu; MCM priority review voucher program Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally, including the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771) Issues involving the Federal, Food, Drug and Cosmetic Act (FFDCA)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Affordable Care Act (ACA); ACA Regulations; ACA Stabilization; Health Reform; Rural Healthcare; Risk Adjustment; State Flexibility; Point of Sale; Fall Priorities; Opioids; Sober Homes; Marketplace Stability; Individual Market Reform; FAA (Air Ambulance); CREATES Act; Sec. 1332 Waivers; Short Term Limited Duration (STLD): AHPs; Value-based Care; Health Care Costs; Mental Health; Small Business Plans; Single Payer; Reinsurance; CSRs; SNPs; Health Savings Accounts (HSAs); Postal Reform; FEHBP Options; 42 CFR Part 2; Transparency; Silverloading; Health IT Interoperability; Urban Affairs/Deterrence (Opioid epidemic); Texas lawsuit; Air Ambulance; Surprise billing, Transparency, Small Business, State Flexibility; Lyme Disease 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 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 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 3325 ACE Kids Act Introduced July 20, 2017 by Joe Barton (R-TX) To amend title XIX of the Social Security Act to provide States with the option of providing coordinated care for children with complex medical conditions through a health home, and for other purposes. HR 6294 REVAMP Act Introduced June 28, 2018 by John Shimkus (R-IL) To amend the Federal Food, Drug, and Cosmetic Act to encourage the development of priority antimicrobial products through the award of a transferable exclusivity extension period, and for other purposes. HR 6733 Know the Cost Act of 2018 Introduced September 7, 2018 by Buddy Carter (R-GA) To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to prohibit group health plans, health insurance issuers, prescription drug plan sponsors, and Medicare Advantage organizations from limiting certain information on drug prices.

Client expense: $1,590,000 · Firm income: Not reported

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

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.

Client expense: $1,540,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, 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. Drug Shortages. 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. S.3792: Preserve Access to Affordable Generics and Biosimilars 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. Pharmaceutical 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. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. 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. S.3680: Low Drug Prices 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. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $1,570,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)

S. 974/HR2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180-day exclusivity periods; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; Federal policy relating to generic pharmaceutical drug prices; Public Law 115-52, the FDA Reauthorization Act of 2017, Section 808, Incentivizing Generic Drug Developments, provisions relating to exclusivity for competitive generic therapies; and Federal policy relating to FDA proposed rule Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, Docket No. FDA-2007-N-0363, RIN 0910-AG18

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation to address abuses of the REMS program to allow generic drugs to come to market faster. H.R.2212/S.974: CREATES Act--provisions related to removing barriers to generic competition. H.R.1316: The Prescription Drug Price Transparency Act--issues related to ensuring the continuity of MAC pricing. Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs, provisions affecting market competition for prescription drugs and the drug supply chain.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

General education about the pharmacy benefit manager/pharmacy industry, including S.637, The Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act. Issues related to Risk Evaluation and Mitigation Strategies (REMS) program, including S.974 and H. R. 2212, The CREATES Act. Proactive measures to curb opioid abuse, including H. R. 3528, Every Prescription Conveyed Securely Act, and H. R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018, as well as H.R. 6, the SUPPORT for Patients and Communities Act.

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

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974/ H.R. 2212 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); to clarify the regulatory framework with respect to certain nonprescrption drugs that are marketed without an approved new drug application. General lobbying with regard to the federal preemption of state causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph federal preemption issues.

Client expense: $1,300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 6689/S. 3368, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers. Advocate against including physician advocacy and membership organization in the Physician Payment Sunshine Act requirements as originally included in S. 3000; advocated against inclusion in S. Amendment 4013 to H.R. 6.

Client expense: $360,000 · Firm income: Not reported

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

Support the CREATES Act, H.R. 2212 and S. 974. Support the 340 B Drug Pricing Program.

Client expense: Not reported · Firm income: Not reported

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

General education about the generic and biosimilar pharmaceutical industry. Issues related to affordability, including the pricing of pharmaceuticals and access to generics and biosimilars, including H. R. 2212 and S. 974, the CREATES Act of 2017, and H.R. 2051, the Fair Access for Safe and Timely Generics (FAST) Generics Act of 2017. H.R. 6. SUPPORT for Patients and Communities Act.

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

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)