Patient Right to Know Drug Prices Act

Essential emergency medication shortages Mental health services for emergency psychiatric patients Price transparency, out-of-network reimbursement of emergency medical services H.Res.906-Congratulating the American College of Emergency Physicians on its 50th anniversary H.R.6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R.372-Competetive Health Insurance Reform Act of 2017 H.R.548-Health Care Safety Net Enhancement Act of 2017 H.R.767-Stop, Observe, Ask, and Respond (SOAR) to Health and Wellness Act of 2017 H.R.817-End Surprise Billing Act of 2017 H.R.880-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act H.R.1057-Synthetics Trafficking and Overdose Prevention Act of 2017 H.R.1215-Protecting Access to Care Act of 2017 H.R.1323-Reducing Unnecessary Emergency Room Visits under Medicaid Act H.R.1492-Medical Controlled Substances Transportation Act of 2017 H.R.1565-Saving Lives, Saving Costs Act H.R.1822-Good Samaritan Health Professionals Act of 2017 H.R.1876-Good Samaritan Health Professionals Act of 2017 H.R.2200-Frederick Douglass Trafficking Victims Prevention and Protection Reauthorization Act of 2017 H.R.2410-Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2017 H.R.2851-Stop the Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017 H.R.2957-Save Rural Hospitals Act H.R.3181-Medicare Choices Empowerment and Protection Act H.R.3258-Marketplace Certainty Act H.R.3545-Overdose Prevention and Patient Safety (OPPS) Act H.R.4922-Stopping Overdoses of Fentanyl Analogues Act H.R.5176-Preventing Overdoses While in Emergency Rooms Act of 2018 H.R.5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R.5531-Opioid Emergency Response Act H.R.5558-Alternatives to Opioids Prescribing Act H.R.5678-Rural Emergency Medical Center Act of 2018 H.R.5734-Resident Education Deferred Interest Act H.R.6082-Overdose Prevention and Patient Safety (OPPS) Act H.R.6143-Patient Right to Know Drug Prices Act H.R.6144-Know the Lowest Price Act of 2018 H.R.6372-To require the Secretary of Health and Human Services issue regulations to ensure due process rights for physicians furnishing emergency medical services H.R.6502-Reducing Unnecessary Senior Hospitalizations Act of 2018 H.R.6733-Know the Cost Act of 2018 Senate resolution congratulating the American College of Emergency Physicians on its 50th anniversary S.191-Patient Freedom Act of 2017 S.256-SOAR to Health and Wellness Act of 2017 S.284-End Surprise Billing Act of 2017 S.372- Synthetics Trafficking and Overdose Prevention Act of 2017 S.527-Health Care Safety Net Enhancement Act of 2017 S.568-Improving Access to Medicare Coverage Act of 2017 S.781-Good Samaritan Health Professionals Act of 2017 S.1016-Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act of 2017 S.1022-Military Injury Surgical Systems Integrated Operationally Nationwide to Achieve ZERO Preventable Deaths Act S.1130-Rural Emergency Acute Care Hospital (REACH) Act S.1462-Marketplace Certainty Act S.1530- Medicare Choices Empowerment and Protection Act S.1553-Stopping Overdoses of Fentanyl Analogues Act S.1835-Lower Premiums Through Reinsurance Act of 2017 S.2465-Sickle Cell Disease Research, Surveillance, Prevention, and Treatment Act of 2018 S.2516-Alternatives to Opioids (ALTO) in the Emergency Department Act S.2544-Patient Right to Know Drug Prices Act S.2553-Know the Lowest Price Act of 2018 S.2609-Recovery Coaches Offer Addiction Counseling and Healing (COACH) Act S.2610-Preventing Overdoses While in Emergency Departments Act of 2018 S.2680-Opioid Crisis Response Act of 2018 S.3531-Emergency Care Improvement Act

Client expense: $402,721 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5515-John S. McCain National Defense Authorization Act for Fiscal Year 2019 H.R.6143-Patient Right to Know Drug Prices Act H.R.6144-Know the Lowest Price Act of 2018 H.R.6733-Know the Cost Act of 2018 S.2544-Patient Right to Know Drug Prices Act S.2553-Know the Lowest Price Act of 2018 S.2987-John S. McCain National Defense Authorization Act for Fiscal Year 2019

Client expense: $402,721 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks. Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, Direct and Indirect Remuneration (DIR), pharmacy networks, and mail-service pharmacy. Issues included in the Part D Rule and accompanying RFI. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. 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.3528, The Every Prescription Carried Safely Act 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.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018

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

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.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 ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act 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.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

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

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

Issues related to health care, including employee health care plans, and the Patients Right to Know Drug Prices Act (H.R. 6143 / S. 2554).

Client expense: $3,710,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Financial Protection Bureau (CFPB), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Education, Dept of, Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Aeronautics & Space Administration (NASA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), Postal Regulatory Commission, SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. Postal Service (USPS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Drug pricing; SUPPORT for Patients and Communities Act (H.R. 6); Biosimilars Competition Act of 2018 (H.R. 6478); Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143); Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505); Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519); citizen petitions; Medicare Part B international reference pricing; Hatch-Waxman Integrity Act of 2018 (S. 3738/H.R. 7251); Affordable Drug Manufacturing Act of 2018 (H.R. 7348/S. 3775); Preserve Access to Affordable Generics and Biosimilars Act (S. 3792); Direct-to-consumer pharmaceutical advertising.

Client expense: Not reported · Firm income: $320,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)

Federal funding opportunities to combat opioid addiction. S.2553, H.R.6144,H.R.6143

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

Government targets: Agriculture, Dept of (USDA), Economic Development Administration, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), SENATE, Transportation, Dept of (DOT)

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; 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. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act; H.R. 7339, Medicare for America Act of 2018; Proposed Rule, "Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses, CMS-4180-P"

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 1408, Access to Insurance for All Americans Act H.R. 1628, American Health Care Reform Act H.R. 2400, to Allow Persons not Federal Employees to enroll in FEHBP H.R. 5965, Access to Infertility Treatment and Care Act S. 2960, Access to Infertility Treatment and Care Act H.R. 6143, Patient Right to Know Drug Prices Act S. 2554, Patient Right to Know Drug Prices Act H.R. 6733, Know the Cost Act of 2018

Client expense: $200,000 · Firm income: Not reported

Government targets: Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

Issues related to pharmaceutical prices. H.R. 6, SUPPORT for Patients and Communities Act; S.2680, Opioid Crisis Response Act of of 2018 and issues related to controlled substances; monitored S. 2554 / H.R. 6143, the Patient Right to Know Drug Prices Act; monitored H.R. 3325, the Advancing Care for Exceptional Kids Act (ACE Kids) and H.R. 7212, IMPROVE Act. S. 1194, Medical Nutrition Equity Act. H.R. 4724, Medicare IVIG Access Enhancement Act.

Client expense: Not reported · Firm income: $52,500

Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

No bill, lobbied to raise awareness about Atrial Fibrillation and stroke prevention. No bill, lobbied regarding biosimilars issues including naming, labeling and interchangeability. H.R. 1245 and S. 469, Affordable and Safe Prescription Drug Importation Act, lobbied regarding all biopharmaceutical provisions. H.R. 1703, Medical Product Communications Act of 2017, regarding all biopharmaceutical related provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues Act of 2017, regarding all biopharmaceutical related provisions No bill, lobbied for changes to the 340B Drug Discount Program. H.R. 4710, 340B PAUSE Act, lobbied regarding all biopharmaceutical provisions. H.R. 4392, a bill to repeal the HOPPS final regulation related to changes in the payment amount for certain drugs under the 340B program, lobbied regarding all biopharmaceutical provisions. H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act of 2017, lobbied regarding all biopharmaceutical provisions. S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act, regarding all biopharmaceutical related provisions. S.2453, Ensuring the Value of the 340B Program Act of 2018, regarding all biopharmaceutical related provisions. H.R. 5598 340B Optimization Act, regarding all biopharmaceutical related provisions. H.R. 6071 SERV Communities Act, regarding all biopharmaceutical related provisions. H.R. 6240, Drug Discount Accountability Act, regarding all biopharmaceutical related provisions. H.R. 6143, S. 2554, Patient Right to Know Drug Prices Act, regarding all biopharmaceutical related provisions. H.R. 6, SUPPORT for Patients and Communities Act, regarding all biopharmaceutical related provisions.

Client expense: $940,000 · Firm income: Not reported

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

Issues related to implementation of the 21st Century Cures Act (Public Law No: 114-255); in general H.R. 5311/S. 2456, the CARA 2.0 Act of 2018 H.R. 2556/S. 1016, the Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act S. 1850, the Protecting Jessica Grubbs Legacy Act H.R. 3545, the Overdose Prevention and Patient Safety Act Docket ID: SAMHSA-4162-20, Confidentiality of Substance Use Disorder Patient Records Issues relating to the reauthorization of the Childrens Health Insurance Program H.R. 3192/S. 2253, the CHIP Mental Health Parity Act S. 774, the Trauma-Informed Care for Children and Families Act H.R. 4778/S. 2301, the Behavioral Health Coverage Transparency Act S. 2406/H.R. 5002, the Advancing Cutting-Edge (ACE) Research Act H.R. 5102/S. 2524, the Substance use Disorder Workforce Loan Repayment Act Issues relating to market stabilization for the Affordable Care Act Issues related to opioids. Issues related to gun violence and mental health, in general H.R. 2276/S. 2575, the Audiology Patient Choice Act H.R. 6, SUPPORT for Patients and Communities Act S. 2680, the Opioid Crisis Response Act H.R. 994, the Examining Opioid Treatment Infrastructure Act H.R. 1375, a bill to amend the Public Health Service Act to authorize the Secretary of Health of Human Services to award grants to States (or collaborations of States) to establish, expand, or maintain a comprehensive regional, State, or municipal system to provide training, education, consultation, and other resources to prescribers relating to patient pain, substance misuse, and substance abuse disorders, and for other purposes. S. 581/H.R. 5009, Jessie's Law H.R. 2077, theRestoring the Patient's Voice Act H.R. 2345, the National Suicide Hotline Improvement Act S. 1354, a bill to establish an Individual Market Reinsurance fund to provide funding for State individual market stabilization reinsurance programs. H.R. 3692, the Addiction Treatment Access Improvement Act H.R. 3931/S.1905, the Excellence in Mental Health and Addiction Treatment Expansion Act H.R. 4733/S. 2260, the Opioids and STOP Pain Initiative Act S. 2317, a bill to amend the Controlled Substances Act to provide for additional flexibility with respect to medication-assisted treatment for opioid use disorders, and for other purposes. H.R. 4903, Combating Opioid Misuse By Advancing Treatment (COMBAT) Act H.R. 5083, the Expanding Access to Evidence-Based Opioid Treatment for Seniors Act H.R. 5327, the Comprehensive Opioid Recovery Centers Act H.R. 5385/S. 2597, the Children's Hospital GME Support Reauthorization Act S. 2606, the Opioid ECHO Act H.R. 5795, the Overdose Prevention and Patient Safety Act H.R. 5483, the Special Registration for Telemedicine Clarification Act H.R. 6082, the Overdose Prevention and Patient Safety Act S.3337, the Mental Health Services for Students Act H.R.6597, the Mental Health Professionals Workforce Shortage Loan Repayment Act S. 2554, the Patient Right to Know Drug Prices Act H.R. 6143, the Patient Right to Know Drug Prices Act Issues relating to suicide prevention; in general Issues relating to the enforcement of mental health parity; in general

Client expense: $250,000 · Firm income: Not reported

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

H.R. 1245/S. 469 The Affordable and Safe Prescription Drug Importation Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 749 Lower Drug Costs Through Competition H.R.2430/S. 934 - FDA Reauthorization Act of 2017 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 6733 - Know the Cost Act H.R. 6143/ S. 2554 - Patient Right to Know Drug Prices Act H.R. 6144/ S. 2553 - Know the Lowest Price Act H.R. 6641 - True Cost-sharing of Seniors Drugs Transparency (True COST) Act H.R. 5958 - Phair Pricing Act

Client expense: $640,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), 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: $656,680 · 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

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. Regulatory design and coverage of pharmacy benefits. Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.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 ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act 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.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Client expense: $656,680 · 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

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks. Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, Direct and Indirect Remuneration (DIR), pharmacy networks, and mail-service pharmacy. Issues included in the Part D Rule and accompanying RFI. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. 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.3528, The Every Prescription Carried Safely Act 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.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018

Client expense: $656,680 · 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

Issues related to health care, including employee health care plans, and the Patients Right to Know Drug Prices Act (H.R. 6143 / S. 2554).

Client expense: $3,630,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Defense, Dept of (DOD), Education, Dept of, Executive Office of the President (EOP), Federal Aviation Administration (FAA), Federal Communications Commission (FCC), Federal Reserve System, Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Aeronautics & Space Administration (NASA), Natl Economic Council (NEC), Natl Institute of Standards & Technology (NIST), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), Postal Regulatory Commission, SENATE, Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Copyright Office, U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. Postal Service (USPS), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 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. 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. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

Client expense: $1,130,000 · Firm income: Not reported

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

Issues related to prescription drug abuse, medication adherence, drug price transparency, and gag clauses. H.R. 1316, The Prescription Drug Price Transparency Act of 2017 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 S. 2554/H.R. 6143, The Patient Right to Know Drug Prices Act of 2018 H.R. 5343, The Prescription Transparency Act of 2018 H.R. 6, The SUPPORT for Patients and Communities Act of 2018 S. 2680, The Opioids Crisis Response Act

Client expense: $1,442,000 · Firm income: Not reported

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

Issues related to pharmaceutical prices. H.R. 6, SUPPORT for Patients and Communities Act; S.2680, Opioid Crisis Response Act of of 2018 and issues related to controlled substances; monitored S. 2554 / H.R. 6143, the Patient Right to Know Drug Prices Act; monitored H.R. 3325, the Advancing Care for Exceptional Kids Act (ACE Kids). S. 1194, Medical Nutrition Equity Act. H.R. 4724, Medicare IVIG Access Enhancement Act.

Client expense: Not reported · Firm income: $52,500

Government targets: HOUSE OF REPRESENTATIVES, Office of the Vice President of the United States, SENATE

Monitored issues related to drug pricing; issues related to Part D drug benefit. S. 2554 / H.R. 6143, Patient Right to Know Drug Prices Act.

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

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

Client expense: $5,990,000 · Firm income: Not reported

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1408, Access to Insurance for All Americans Act H.R. 1628, American Health Care Reform Act H.R. 2400, to Allow Persons not Federal Employees to enroll in FEHBP H.R. 5965, Access to Infertility Treatment and Care Act S. 2960, Access to Infertility Treatment and Care Act H.R. 6143, Patient Right to Know Drug Prices Act S. 2554, Patient Right to Know Drug Prices Act H.R. 6733, Know the Cost Act of 2018

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

Government targets: Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

No bill, lobbied to raise awareness about Atrial Fibrillation and stroke prevention. No bill, lobbied regarding biosimilars issues including naming, labeling and interchangeability. H.R. 1245 and S. 469, Affordable and Safe Prescription Drug Importation Act, lobbied regarding all biopharmaceutical provisions. H.R. 1703, Medical Product Communications Act of 2017, regarding all biopharmaceutical related provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues Act of 2017, regarding all biopharmaceutical related provisions No bill, lobbied for changes to the 340B Drug Discount Program. H.R. 4710, 340B PAUSE Act, lobbied regarding all biopharmaceutical provisions. H.R. 4392, a bill to repeal the HOPPS final regulation related to changes in the payment amount for certain drugs under the 340B program, lobbied regarding all biopharmaceutical provisions. H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act of 2017, lobbied regarding all biopharmaceutical provisions. S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act, regarding all biopharmaceutical related provisions. S.2453, Ensuring the Value of the 340B Program Act of 2018, regarding all biopharmaceutical related provisions. H.R. 5598 340B Optimization Act, regarding all biopharmaceutical related provisions. H.R. 6071 SERV Communities Act, regarding all biopharmaceutical related provisions. H.R. 6240, Drug Discount Accountability Act, regarding all biopharmaceutical related provisions. H.R. 6143, S. 2554, Patient Right to Know Drug Prices Act, regarding all biopharmaceutical related provisions. H.R. 6, SUPPORT for Patients and Communities Act, regarding all biopharmaceutical related provisions.

Client expense: $960,000 · Firm income: Not reported

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

Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Drug pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; CREATES Act (HR 2212/S. 974; 340B issues; SUPPORT for Patients and Communities Act (H.R. 6), Biosimilars Competition Act of 2018 (H.R. 6478), Patient Right to Know Drug Prices Act (S. 2554/H.R. 6143), Re-Valuing Anti-Microbial Products Act of 2018 (H.R. 6294), Medicare Negotiation and Competitive Licensing Act of 2018 (H.R. 6505), Making Objective Drug Evidence Revisions for New (MODERN) Labeling Act (S. 3519), citizen petitions

Client expense: Not reported · Firm income: $270,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

H.R. 1409 Cancer Drug Parity Act; S. 2554/HR. 6143 Patient Right to Know Drug Prices Act; Opioid Monitoring; Drug pricing Monitoring; S. 2680 Opioid Crisis Response Act; H.R.6 Support for Patients and Communities Act.

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

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; 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. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans; H.R. 6733, Know the Cost Act of 2018; H.R. 6641, COST Act

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

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Small Business Administration (SBA), Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

H.R. 1245/S. 469 The Affordable and Safe Prescription Drug Importation Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 749 Lower Drug Costs Through Competition H.R.2430/S. 934 - FDA Reauthorization Act of 2017 H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 6733 - Know the Cost Act H.R. 6143/ S. 2554 - Patient Right to Know Drug Prices Act H.R. 6144/ S. 2553 - Know the Lowest Price Act H.R. 6641 - True Cost-sharing of Seniors Drugs Transparency (True COST) Act H.R. 5989 - Fair Pricing Act

Client expense: $440,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

Issues related to prescription drug abuse, medication adherence, drug price transparency, and gag clauses. H.R. 1316, The Prescription Drug Price Transparency Act of 2017 S. 778/H.R. 1854, The Prescription Drug Monitoring Act of 2017 S. 2460/H.R. 3528, The Every Prescription Conveyed Securely Act of 2017 S. 892/H.R. 4408, The Opioid Addiction Prevention Act of 2017 S. 2456/H.R. 5311, The CARA 2.0 Act of 2018 S. 2553/H.R. 6144, The Know the Lowest Price Act of 2018 S. 2554/H.R. 6143, The Patient Right to Know Drug Prices Act of 2018 H.R. 5343, The Prescription Transparency Act of 2018 H.R. 6, The SUPPORT for Patients and Communities Act of 2018 H.R. 6133, The Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018

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

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

H.R.5723 - Expanding Oversight of Opioid Prescribing and Payment Act of 2018 H.R.5739 - Prescription Drug and Medical Device Price Review Board Act of 2018 S.2981 - Opioid Overdose Reduction Act of 2018 H.R.6143 - Patient Right to Know Drug Prices Act H.R.6133 - Informing Opioid Prescribing Through Evidence-Based Guidelines Act of 2018

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

H.R. 1316, Prescription Drug Price Transparency Act; H.R. 1038, Improving Transparency and Accuracy in Medicare Part D Spending Act; S. 413, Improving Transparency and Accuracy in Medicare Part D Spending Act; H.R. 592, Pharmacy and Medically Underserved Areas Enhancement Act; S. 109, Pharmacy and Medically Underserved Areas Enhancement Act; H.R.1939 - To amend title XVIII of the Social Security Act to ensure equal access of Medicare beneficiaries to community pharmacies in underserved areas as network pharmacies under Medicare prescription drug coverage, and for other purposes; S.637 Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; HR 394/ S 85, Restoring Access to Medication Act; HR 3921/S 1827, KIDS Act of 2017; HR 3271, Protecting Access to Diabetes Supplies Act of 2017; S. 870, Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017; Centers for Medicare and Medicaid Services (CMS) Proposed Rule for the 2019 Medicare Part D Plan Year, pharmacy provisions; 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. 5343, Prescription Transparency Act of 2018; H.R. 5958, Phair Pricing Act of 2018; CMS Call Letter for 2019 Medicare Part D and Medicare Advantage Plans

Client expense: $320,000 · Firm income: Not reported

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Personnel Management (OPM), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office

Issues related to pharmacy contracting with respect to drug pricing and pharmacy networks. Regulatory and proposed legislative changes to Medicare Part D pharmacy contracting, Direct and Indirect Remuneration (DIR), pharmacy networks, and mail-service pharmacy. Issues included in the Proposed Part D Rule and accompanying RFI. Issues related to Medicaid Provider Enrollment. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse. Issues related to pharmacy gag clauses. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. 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.3528, The Every Prescription Carried Safely Act 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.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018

Client expense: $766,889 · 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

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. 1703, Medical Product Communications 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.1703 Medical Product Communications Act 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.3447, Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 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, FDA user fees, manufacturer market and data exclusivity, REMS, accelerated generic approval, bio-similars.

Client expense: $766,889 · 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

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Regulatory and proposed legislative changes to Medicare Part D including non-interference, Direct and Indirect Remuneration (DIR), pharmacy networks, classes of clinical concern, mail-service pharmacy and safe harbors related to manufacturer rebates. Issues related to the management of Medicaid prescription drug benefits. Issues related to prescription drug abuse in Medicare and Medicaid. Provisions of PL 111-148 and PL 111-152 impacting Medicare Part D such as formulary requirements, PBM disclosure provisions, implementation of the prescriber registration rules and definition of negotiated price. 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). Issues related to Medicaid Provider Enrollment. Issues related to the Medicare Coverage Gap Discount. H.R.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 ActH.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies ActH.R.3528/S.2460, The Every Prescription Carried Safely Act 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.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R.5958, Fair Pricing Act of 2018 H.R.5343, Prescription Transparency Act of 2018

Client expense: $766,889 · 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

H.R. 1409 Cancer Drug Parity Act; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; S. 2554/HR. 6143 Patient Right to Know Drug Prices Act; Opioid Monitoring; Drug pricing Monitoring, HR. 592/ S. 109 Pharmacy and Medically Underserved Areas Enhancement Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE