Medicare Negotiation and Competitive Licensing Act of 2018

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

Medicare Part B coverage and reimbursement issues Coding and reimbursement for biologics/biosimilars HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill S. 1676 Chronic Kidney Disease Improvement in Research and Treatment Act; Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues H.R. 6142 Reducing Drug Waste Act of 2018 Issues related to the 340b program, no specific bill Drug Price Transparency Bills: oHR 2296/S 1391 FAIR Drug Pricing Act oHR 2113 Prescription Drug STAR Act oHR 2069 SPIKE Act S 1416 Affordable Prescriptions for Patients Act Issues related to Direct to Consumer Advertisement S. 551, Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act S. 476, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act H.R. 2087, Drug Price Transparency Act

Client expense: $2,200,000 · Firm income: Not reported

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

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

HR 1046/S 377-Medicare negotiation and competitive licensing act, HR 938-BLOCKING ACT, hr 965/s340- (creates ACT), HR 1503-Orange book transparency act, HR 1520-Purple book continuity act, HR 1499-Protecting consumer access to generic drugs act, S 64-preserve access to affordable generics and biosimilars act, drug pricing, HR 2113-Prescription drug STAR act, HR 1093/S 378 (Stop price gouging act, HR 1344-Competitive drugs act, HR 465/S 102-Prescription drug price relief act, HR-3379- PRICED act, affordable drug manufacturing act, S 1416-Affordable prescriptions to patients act, HR 2374/S 1224 (stop STALLING act) HR 2917 Opioid Crisis accountability act, S 1209-REMEDY ACT, hr 6505 Medicare Negotiation and competitive Licensing act, SEC 101-Patent reform legislation

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

Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues, no specific bill

Client expense: $3,250,000 · Firm income: Not reported

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

H.R. 1046 Medicare Negotiation and Competitive Licensing Act of 2019 H.R. 5340 STRONGER Patents Act of 2018 H.R. 6505 Medicare Negotiation and Competitive Licensing Act of 2018 -- regarding the effect on higher education institutions.

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

Government targets: Bureau of Citizenship & Immigration Services (BCIS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

1) Support Rohrabacher-Blumenauer (previously Rohrabacher-Farr) amendment prohibiting use of federal funds to prevent states from implementing medical marijuana laws. H.R. 1625 2) Against H.R. 6505 - Medicare part D drug price negotiation. 3) Launched Taxpayers Against Illicit Opioids. No specific legislation.4) Against Advanced Notice of Proposed Rule Making to create an International Pricing Index for drugs under Medicare Part B.

Client expense: Not reported · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

1) Support Rohrabacher-Blumenauer (previously Rohrabacher-Farr) amendment prohibiting use of federal funds to prevent states from implementing medical marijuana laws. H.R. 1625 2) Against H.R. 6505 - Medicare part D drug price negotiation. 3) Launched Taxpayers Against Illicit Opioids. No specific legislation.

Client expense: Not reported · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

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

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

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

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies HR 1892 - Bipartisan Budget Act of 2018, provision related to Medicare Part D Doughnut Hole H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Final Rule; Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System changes for 2019 (CMS-1695-FC) Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing Proposed Rule (CMS-4180-P) Medicare Part D/Medicare Part B Medicaid Protected Classes

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)

Outreach and monitoring related to federal student aid and Pell grants. Outreach and monitoring related to university technology transfer, compulsory licensing, and intellectual property issues. Outreach and monitoring related to higher education reauthorization. H.R. 4508, PROSPER Act. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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)

H.R. 5340 STRONGER Patents Act of 2018 H.R. 6505 Medicare Negotiation and Competitive Licensing Act of 2018 S. 1390 STRONGER Patents Act of 2017 -- regarding the effect on higher education institutions.

Client expense: $52,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3192: CHIP Mental Health Parity Act H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5590: Opioid Addiction Action Plan Act H.R. 5605: Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 5810: Medicaid Health Homes for Opioid-Use-Disorder Medicaid Enrollees Encouraged Act H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 - Drug pricing H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. 7217: Improving Medicaid Programs and Opportunities for Eligible Beneficiaries Act or IMPROVE Act S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues False Claims Act policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Changes to the Medicare Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Prescription drug abuse policy issues ANPRM; Medicare Program; International Pricing Index Model for Medicare Part B Drugs (CMS-5528-ANPRM) Proposed Rule; Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency (CMS-4187-P) Proposed Rule; Contract Year (CY) 2020 Medicare Advantage and Part D Drug Pricing (CMS-4180-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08)

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

Bayh-Dole Act/Tech Transfer ---March-In Rights Intellectual Property International Enforcement ---Compulsory Licensing ---Chile ---Malaysia ---India Inter Partes Review ---Implementation of the America Invents Act of 2011 ---H.R. 5340/S. 1390: STRONGER Patents Act ---H.R. 6264: Restoring America's Leadership Act ---H.R. 7251: Hatch-Waxman Integrity Act of 2018 The United States-Mexico-Canada Agreement ---IP Provisions Patent Reform ---H.R. 5340/S. 1390: STRONGER Patents Act Compulsory Licensing in Federal Programs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 Small Business IP Training ---H.R. 2655/S.791: Small Business Innovation Protection Act of 2017 Drug Patent Settlements Patenting of Biological Inventions ---Section 101 Modernization US-UK Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions

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

Medicaid ---Drug Benefit Design ---Pricing and Rebates ---Average Manufacturer Price Calculation Reimbursement for Innovative Products ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications ---S. 1688: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2017 ---S. 771: Improving Access to Affordable Prescription Drugs ---H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018

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

Issue: Educate Congress on perspectives from the higher education community regarding technology transfer, the importance of the Bayh-Dole Act to the US patent system, and the impact of sovereign immunity claims on challenges to patents. H.R.5340, STRONGER Patents Act Issue: Support efforts to improve and prevent abuse of the U.S. patent system P.L. 115-273, SUCCESS Act Issue: Support legislation for USPTO to study and report on number of patents by various entities. H.R.6505, Medicare Negotiation and Competitive Licensing Act of 2018 Issue: Support intellectual property protections.

Client expense: $892,000 · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Agriculture, Dept of (USDA), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Natl Science Foundation (NSF), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Substance Abuse & Mental Health Services Administration (SAMHSA), Veterans Affairs, Dept of (VA), Vice President of the U.S., White House Office

H.R. 6505 - Medicare Negotiation and Competitive Licensing Act of 2018 (entire bill) 340B issues (no specific bill)

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

Government targets: HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), Patent & Trademark Office (PTO), SENATE

Issues pertaining to the Affordable Care Act; prescription drug costs/pricing; HR 6505, Medicare Negotiation & Competitive Licensing Act of 2018, and issues relating to Medicare Parts B and D.

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

Government targets: HOUSE OF REPRESENTATIVES

H.R.6505 - Medicare Negotiation and Competitive Licensing Act - require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program Oral health -Medicare dental benefit; Medicare coverage of medically necessary oral health care S.3770 - Medicaid Drug Decisions Transparency Act - expand the scope of transparency reporting requirements related to the ownership or investment interests of health care providers and others, and to increase the penalties associated with violating such requirements H.R. 7217 - IMPROVE Act - extend the Medicaid HCBS spousal impoverishment protections through March and reauthorize the Money Follows the Person Program with 3 months of funding H.R. 6 - Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act - Section 5021, 5022 - H.R. 3192, the CHIP Mental Health Parity Act; Section 5031, 5032 - H.R. 4005, the Medicaid Reentry Act; S.3462 - Improving Coverage for Substance Use Disorder Recovery Expansion Act - provide States with the option to provide medical assistance for substance use disorder treatment services to individuals; modification of IMD exclusion H.R. 5797 - Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Execution Act - partial removal of IMD exclusion Legislation to expand Medicare coverage Legislation around discounts the pharmaceutical industry must provide for drugs purchased in the Medicare Part D donut hole

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

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

H.R. 6505 Medicare Negotiation and Competitive Licensing Act of 2018 White House Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

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

Government targets: Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, White House Office

H.R. 6505 Medicare Negotiation and Competitive Licensing Act of 2018

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

Government targets: Defense, Dept of (DOD), Executive Office of the President (EOP), Federal Communications Commission (FCC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, White House Office

ACA Implementation Association Health Plans Blueprint to Lower Drug Prices and Reduce Out of Pocket Costs Cadillac Tax Delay/Repeal H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018 Health Care Reform Health Insurance Tax Health Savings Accounts H.R. 184, Protect Medical Innovation Act H.R. 6199, Restoring Access to Medication and Mordernizing Health Savings Account International Pricing Index Model for Medicare Part B Drugs ANPRM Medical Device Tax Medicare for All/Single Payer Medicare Part D Opioid Crisis Pharmaceutical Pricing Transparency Tax Treatment of Employer-Sponsored Health Care Wellness Plans

Client expense: $2,840,000 · Firm income: Not reported

Government targets: Bureau of Citizenship & Immigration Services (BCIS), Centers For Medicare and Medicaid Services (CMS), Central Intelligence Agency (CIA), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Export-Import Bank of the United States (EXIM Bank), Federal Communications Commission (FCC), Federal Energy Regulatory Commission (FERC), Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Security Council (NSC), Natl Telecommunications & Information Administration (NTIA), Occupational Safety & Health Administration (OSHA), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Customs & Border Protection, U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR), White House Office

H.R. 3730 H.R. 6505, the Medicare Negotiation and Competitive Licensing Act H.R. 7217, the IMPROVE Act Medicaid Block Grants Proposed Reductions in Medicaid Spending Commission on Long Term Care House Draft Bill on long-term care

Client expense: $65,208 · Firm income: Not reported

Government targets: AMTRAK - Natl Railroad Passenger Corporation, HOUSE OF REPRESENTATIVES, Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Institute of Mental Health (NIMH), SENATE, Transportation, Dept of (DOT), Veterans Affairs, Dept of (VA)

H.R. 849, S. 260, S. 251 Protecting Seniors Access to Medicare Act, lobbied regarding all biopharmaceutical related provisions. S.771, Improving Access To Affordable Prescription Drugs Act, lobbied regarding all biopharmaceutical related provisions. S.348, Prescription Drug and Health Improvement Act of 2017, lobbied regarding all biopharmaceutical related provisions. S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017, lobbied regarding all biopharmaceutical related provisions. No bill, American Patients First Prescription Drug Blueprint, regarding all biopharmaceutical related provisions. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018, regarding all biopharmaceutical related provisions. H.R. 6642, to amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs, regarding all biopharmaceutical related provisions. S. 2553, H.R. 6144, Know the Lowest Price Act of 2018, 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)

1. Patient Protection and Affordable Health Care Act, implementation of provisions regarding Medicare Part D coverage gap assistance, preventive care services, and dual eligible Medicare and Medicare beneficiaries 2. Proposals to create a premium support or voucher program under Medicare 3. Proposals to "means test" Medicare premiums and benefits 4. Proposals to change federal and state Medicaid cost sharing 5. Proposals to raise the Medicare eligibility age 6. Proposals regarding prescription drug costs for low income Medicare beneficiaries 7. Expansion of Medicare benefits to include hearing, vision, and dental benefits 8. Administration of the Medicare State Health Insurance Assistance Programs 9. H.R.1421, Improving Access to Medicare Coverage Act of 2017, entire bill 10. S. 568, Improving Access to Medicare Coverage Act of 2017, entire bill 11. H.R. 1776, Improving Access To Affordable Prescription Drugs Act, entire bill 12. S. 2704, Medicare Beneficiary Opioid Addiction Treatment Act, entire bill 13. Medicare Observation Status Regulations 14. Nursing Home Arbitration Regulations 15. CMS Medicare Handbook and Open Season Materials 16. H.R. 5757, Fighting Medicare Fraud Act of 2018, entire bill 17. Medicare 340(B) drug reimbursement policy 18. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018, entire bill 19. Home care workers and Medicare Reassignment Policy 20. Medicare equitable relief policy 21. Medicare Special Enrollment Period

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA)

Issues related to P.L. 96-517, the Bayh-Dole Act; issues related to drug pricing; issues related to Medicare Part D Coverage; HR 6505 Medicare Negotiation and Competitive Licensing Act

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

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

HR 6505-Medicare Negotiation and competitive licensing act, S 1369/HR 2974-Stop price gouging Act, HR 6577-PRICED Act, S 124-Preserve access to affordable generics act, HR 4117-competitive drugs act, S 974/HR 2212-CREATES act, drug pricing, HR 4116-Transparent drug pricing act, HR 1776-Improving access to affordable prescription drugs act, S 3680-Low Drug Prices act, HR 676-Expanded and Improved Medicare for all act, S 3775-Affordable drug manufacturing act,

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

Government targets: Commodity Futures Trading Commission (CFTC), Federal Deposit Insurance Corporation (FDIC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC), U.S. Trade Representative (USTR)

Hearing Aids. H.R. 3426, Medicare Hearing Aid Coverage Act: Proposal to provide Medicare coverage of hearing aids. Medicare Dental, Vision, and Hearing Coverage. H.R. 508, Seniors Have Eyes, Ears and Teeth Act and H.R. 3111, Medicare Dental, Vision, and Hearing Benefit Act of 2017: Proposals to expand Medicare coverage to include comprehensive coverage of dental, vision, and hearing care. Medicare Observation Status. S. 568/H.R. 1421, Improving Access to Medicare Coverage Act of 2017: Proposal to count days in the hospital in observation status toward meeting the three-day prior hospitalization requirement for skilled nursing facility care eligibility. Dementia and Alzheimers Disease. S. 2076/H.R. 4256, Building Our Largest Dementia Infrastructure for Alzheimers Act (BOLD Act): Proposal to apply a public health approach to combat Alzheimers disease and related dementias. Generic Drug Introduction. S. 974/H.R. 2212, CREATES Act: Proposal to speed the introduction of generic competition by curbing brand drug maker abuses of safety procedures as a means to limit generic manufacturer access to the drug samples needed to obtain Food and Drug Administration approval. Opioid Treatment. H.R. 6, SUPPORT for Patients and Communities Act: Section 2005 proposals related to Medicare coverage of certain services furnished by opioid treatment programs. Medicare Beneficiary Equitable Relief. (No bill): Efforts to extend and make permanent the Centers for Medicare and Medicaid Services policy for equitable relief for select individuals currently or previously enrolled in Affordable Care Act Marketplace plans who delayed Medicare enrollment during their Initial Enrollment Period or during a qualifying Special Enrollment Period. Medicare Physician Payment. (No bill): Proposal to collapse the current five levels of payments for office visits into two levels. Medicare and Medicaid Protection. S. 3330, Medicare and Medicaid Protection Act: Proposed changes to budget reconciliation legislation affecting Medicare and Medicaid program protections. Medicaid Home and Community Based Services. H.R. 7217, IMPROVE Act/H.R. 695, Department of Defense Appropriations Act, 2018: Provisions to extend spousal impoverishment protections to Medicaid home and community based services, and to extend the demonstration program, Money Follows the Person, which provides funding to states to assist people requiring long term care services to stay in their homes. Medicare Prescription Drug Costs. (No bill): Proposals to reduce amount drug manufacturers must contribute to closing the donut hole in 2019. Medicare Prescription Drug Costs. H.R. 6505, Medicare Negotiation and Competitive Licensing Act of 2018: Proposal to allow the Secretary of Health and Human Services to pay another manufacturer to produce a drug in instances where a drug manufacturer fails to provide Medicare a reasonable price for the drug. Medicare Prescription Drug Costs. (No bill): Provisions of the United States-Mexico-Canada Agreement (formerly the North American Free Trade Agreement) addressing countries having expansive regulatory approval monopolies for biologic drugs and restrict the ability of Congress to reform patent laws that drive up drug costs for Medicare. Medicare Part B Drug Costs. (No bill): Proposals to reduce Medicare Part B drug costs by limiting Medicare payment when a drug price increase exceeds an inflation limit. Medicare Open Enrollment. (No bill): Proposals to ensure the Centers for Medicare and Medicaid Services conducts open enrollment in a way that is unbiased toward the traditional program. Medigap reform. (No bill): Proposals to extend Medigap guaranteed issue protections -requiring plans to extend coverage without regard to health status - to all beneficiaires with Medicare Advantage, to disabled beneficiaries under the age of 65 and to beneficiaries with Medigap plans C and F, which will stop taking new enrollees in 2020.

Client expense: $210,000 · Firm income: Not reported

Government targets: Administration on Aging, Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, Social Security Administration (SSA), Treasury, Dept of

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 6505- Medicare Negotiation and Competitive Licensing Act of 2018; Medicare Part D

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

Government targets: HOUSE OF REPRESENTATIVES

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3635: Local Coverage Deteremination Clarification Act of 2018 H.R. 4005: Medicaid Reentry Act H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5675: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries. H.R. 5797: Individuals in Medicaid Deserve Care that is Appropriate and Responsible in its Executive Act H.R. 5799: Medicaid Drug Review, Utilization, Good Governance Improvement Act H.R. 5801: Medicaid PARTNERSHIP Act H.R. 5808: Medicaid Pharmaceutical Home Act of 2018 H.R. 6505: Medicare Negotiation and Competitive Licensing Act of 2018 H.R. 6642: To amend title XIX of the Social Security Act to sunset the limit on the maximum rebate amount for single source drugs and innovator multiple source drugs H.R. __: To amend title XIX of the Social Security Act to provide the Medicare Payment Advisory Commission with access to certain drug rebate information S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 3000: Patient Advocacy Transparency Act - Social Security Act amendments Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues and local coverage decisions Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P) Request for Information: Medicare and State Health Care Programs: Fraud and Abuse; Request for Information Regarding the Anti-Kickback Statute and Beneficiary Inducements CMP; 83 Fed. Reg. 43607 (Aug. 27, 2018) Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection (RIN 0936-AA08) Medicare Part D Doughnut Hole Medicare Part D Cliff S 974/HR 2212 - CREATES Act340B Drug Pricing Program Medicare Part D Six Protected Classes

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