SPIKE Act

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.

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

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

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895, H.R. 133) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package (H.R. 8702/S. 5007, Holding Providers Harmless from Medicare Cuts During COVID-19 Act; S. 8505, a bill to provide a one-year waiver of budget neutrality adjustment under the Medicare Physician Fee Schedule; H.R. 133, Consolidated Appropriations Act, 2021). Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act

Client expense: $310,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R.34: 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---Executive Order on Affordable Life-saving Medications ---H.R. 7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Reimbursement and Coverage of Innovative Products ---Executive order on Lowering Drug Prices by Putting America First Drug Importation ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients Antibiotic & Diagnostic Tax Credit Asia Pacific Economic Cooperation Forum ---Biologics Regulations ---Intellectual Property Issues Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---Implementation of the Families First Coronavirus Response Act of 2020 ---H.R. 748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.4100/S.1712: DISARM Act of 2019 ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---S.4231: Preparing for the Next Pandemic Act of 2020 ---Strategic National Stockpile ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---Executive Order on Buy American ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---National Biodefense Strategy ---Senate HELP Pandemic Preparedness White Paper ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Biosimilar Copay ---BSUFA ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.7917: IGNITE American Innovation Act ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.4775: The Delivering Immediate Relief to America's Families, Schools and Small Business Act ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Coverage for Covid Tx ---Drug Supply Chain Management ---Funding for Countermeasure Injury Compensation Program ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.7269/S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management ---Executive Order on Buy American Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous prices (FLAT) prices Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: Stop The Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---H.R.7614: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---CMMI Authority ---Executive Order on Buy American ---Executive Order on Access to Affordable Life-saving Medications ---Executive Order on Increasing Drug Importation to Lower Prices for American Patients ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---General ---International Pricing Index Proposal ---Most Favored Nation Executive Order ---Proposed Federal Price Caps on COVID-19 Therapeutics and Vaccines Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---S.4760:Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S. 1624: Health, Economic Assistance, Liability Protection, and Schools (HEALS) Act ---Health Defense Operations Funding Designation ---H.R.7537: Infectious Disease Therapies Research and Innovation Act ---H.R.7556: To amend the Internal Revenue Code of 1986 to make a portion of research credit refundable for certain small businesses engaging in specified medical research. ---H.R.7555: To amend the Internal Revenue Code of 1986 to add a new medical research component to the credit for increasing research activities. ---H.R.7537: Infectious Disease Therapies Research and Innovation Act Funding for FDA ---H.R.7610: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovation Benefit Design to Lower Costs for Seniors Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Purchasing (VBP) Rule Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R. 8337: Continuing Appropriations Act, 2021 and other Extensions Act of 2020 ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---Executive Order on Lowering Drug Prices by Putting America First ---Executive Order on Access to Affordable Life-Saving Medications ---Executive Order on Lowering Prices for Patients by Eliminating Kickbacks to Middlemen ---In-Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Value-Based Purchasing (VBP) Rule ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-UK Trade Agreement ---Digital Trade ---IP Provisions ---Market Access ---Regulatory Harmonization Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act of 2020 ---H.R.748: Coronavirus Aid, Relief, and Economic Security (CARES) Act of 2020 ---H.R.6074: Coronavirus Preparedness and Response Supplemental Appropriations Act for FY 2020 ---H.R.7614: Labor, Health and Human services, Education, and Related Agencies Appropriations Act for FY 2021 ---S.4509: Vaccine And Coverage Certainty (VACC) Act ---Adult Immunization Education ---Countermeasure Injury Compensation Program ---Implementation of the Families First Coronavirus Response Act of 2020 ---MCM Manufacturing & Capacity ---MCM R&D Incentives ---Maternal Immunization ---Operation Warp Speed/ACTIV ---S.4760: Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine Injury Compensation Program ---Vaccine Quality Measure ---Vaccine Safety ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,170,000 · 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 Security Council (NSC), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.

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

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

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019. including provisions relating to Anti-microbial Resistance H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 H.R. 6197, Increasing Access to Biosimilars Act of 2020 H.R. 8061, Community Immunity During COVID-19 Act of 2020 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; 340B program integrity; 340B of the Public Health Services Act; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Adult vaccines and immunizations; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; COVID-19 vaccines; Vaccines catch up; Proposed rule on Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products (79 Fed. Reg. 75,506-75,527, December 18, 2014); Coronavirus Aid Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $980,000 · Firm income: Not reported

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

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Improving Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency. Advocate for congressional action to hold health care professionals harmless from any cuts related to CMS Evaluation and Management Code proposals in any forthcoming legislative package. Support H.R. 7233, the KEEP Telehealth Options Act. Oppose H.R 884/S. 2772 the Medicare Mental Health Access Act.

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee 340B Drug Discount Program ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Program Implementation & Oversight Biodefense Research, Development and Procurement Issues (Nonfunding) ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Executive Order on Modernizing Influenza Vaccines ---Gene editing ---Implementation of 21st Century Cures Act of 2016 ---Implementation of Medical Countermeasure Innovation Act of 2016 ---Implementation of Pandemic and All-Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2019 ---National Biodefense Strategy ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---Biosimilar Copay ---Brazil Biologics Regulations ---BSUFA ---Canada Biologics Regulations ---Coding ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Implementation of CREATES Act of 2019 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement Climate Change ---RFI from House Select Committee on the Climate Crisis Coronavirus (COVID-19) Pandemic ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6206: Pandemic Response and Emergency Preparedness (PREP) Act of 2020 ---H.R.6260/S.3545: Reciprocity Ensures Streamlined Use of Lifesaving Treatments for Coronavirus Patients Act of 2020 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---COVID-19 Vaccine and Therapeutic Development ---Drug Supply Chain Management ---Healthcare Disparities ---Home Administration of Part B Drugs ---Liability ---Medicare reimbursement policies ---Patient Cost-Sharing and Smoothing ---Pricing-related Provisions ---R&D Funding for Medical Countermeasures ---Restrictions on Intellectual Property Rights ---Senate HELP Pandemic Preparedness White Paper Drug Evaluation and Review ---S.1617: Second Look at Drug Patents Act of 2019 ---S.3872: Promising Pathway Act ---Compassionate Use/Expanded Access ---Expedited Pathways ---Priority Review Voucher Programs Drug Manufacturing, Quality & Distribution ---Drug Shortages ---Drug Supply Chain Management Drug Patenting ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 Drug Pricing ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1425: The Patient Protection and Affordable Care Enhancement Act of 2020 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---H.R.7288: The Taxpayer Research and Coronavirus Knowledge (TRACK) Act ---S.1416/H.R.4398/H.R.3991/H.R.5133: Affordable Prescriptions for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---CMMI Authority ---General ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Implementation of CREATES Act of 2019 ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Potential Administration Executive Orders ---Pricing-related Provisions Foreign Drug Data Protection Laws ---Regulatory Harmonization Funding for Antimicrobial Resistance Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Health Defense Operations Funding Designation ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for FDA ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2021 Funding for Health Resources and Services Administration (HRSA) - Vaccine Injury Compensation Program (VICP) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for National Institutes of Health ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Funding for 2020-21 Influenza Season Preparedness and Response ---Funding for Routine Immunization Infrastructure during Pandemic ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 Medicaid ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Pricing and Rebates Medicare Expansion ---H.R.5741: Strengthening Innovation in Medicare and Medicaid Act of 2020 Orphan Drug Issues ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 ---H.R.4712: Fairness in Orphan Drug Exclusivity Act of 2019 ---Tax Credit Rare Pediatric Disease Priority Review ---H.R.4439/S.4010: Creating Hope Reauthorization Act of 2019 Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.5122: To prohibit further action on the proposed rule regarding testing of Medicare Part B Prescription Drug Models ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---S.2326: New Opportunities for Value that Extend Lives (NOVEL) Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Home Administration of Part B Drugs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing and Smoothing ---Protected Classes ---Step Therapy ---Support of Patient Premiums and Cost-Sharing Obligations ---Surprise Billing ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement (USMCA) ---Implementation of United States-Mexico-Canada Agreement (USMCA) ---IP Provisions Trade and Foreign Drug Price Controls US-China Trade Agreement ---IP Provisions US-EU Trade Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions US-Kenya Trade Agreement ---IP Provisions US-UK Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---H.R.4100/S.1712: DISARM Act of 2019 ---H.R.5076/S.1872: Protecting Seniors through Immunizations Act of 2019 ---H.R.6800: Health and Economic Recovery Omnibus Emergency Solutions Act (HEROES) Act of 2020 ---Adult Immunization Education ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2021 ---Maternal Immunization ---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act of 2020 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,320,000 · 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 Security Council (NSC), 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), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.

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

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

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act H.R. 5076, Protecting Seniors Through Immunization Act of 2019 S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146)

Client expense: $2,620,000 · 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. 3, Elijah E. Cummings Lower Cost Drugs Now Act. S. 2543, the Prescription Drug Pricing Reduction Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S. 474/H.R. 2069, the SPIKE Act. H.R. 1425, the Patient Protection and Affordable Care Enhancement Act. H.R. 7288, the Taxpayer Research and Coronavirus Knowledge (TRACK) Act. S. 2543, Prescription Drug Pricing Reduction Act (Grassley-Wyden). H.R. 19/S. 3129, Lower Cost More Cures Act.

Client expense: $1,770,000 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Corporation for Natl & Community Service, Federal Communications Commission (FCC), Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Indian Health Service, Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548). Support the Coronavirus Health Care Worker Wellness Act (H.R. 7255) to help promote mental health wellness among physicians and other health care workers during the Public Health Emergency.

Client expense: $340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support reintroduction of Patients Access to Treatments Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support sunscreen related provisions in H.R. 269, the Pandemic & All Hazards Preparedness & Advancing Innovation Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for access to dermatological procedures for veterans through the VA MISSION Act (Public Law 115-182). Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895) Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services. Support legislation to address drug shortages by providing additional authority to the Food and Drug Administration (FDA) to ensure a stable supply of medications (S. 2723, Mitigating Emergency Drug Shortages Act; H.R. 6080, Preventing Drug Shortages Act). Similar provisions to mitigate drug shortages included in CARES Act (H.R. 748, S. 3548). Request resources to provide personal protection equipment (PPE) and supplies and relief from Medicare payment sequester and relief from penalties in Merit-based Incentive Payment System (MIPS) under MACRA in the CARES Act (H.R. 748, S. 3548).

Client expense: $410,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act; H.R. 4712, Fairness in Orphan Drug Exclusivity Act.

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

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

HIPAA and 42 CFR Part 2 patient confidentiality reforms (H.R.2062/S.1012); H.R.3, the "Lower Drug Costs Now Act of 2019," all sections of the bill, and "The Lower Health Care Costs Act", S. 1895. Drug pricing legislation including the Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); FAIR drug pricing act (S.1391); the SPIKE Act (H.R.2069); Second Look at Drug Patents Act (S.1617); and legislation/language incentivizing transparent pharmacy benefit managers (PBMs). Legislation related to the COVID-19 Public Health Emergency: S.3548, the Coronavirus Aid, Relief and Economic Security (CARES) Act. Issues included premium support for small businesses, establishing a federal reinsurance pool, and risk corridors for the health insurance exchanges. Advocated for immediately opening a special enrollment period for the health insurance exchanges and for delay of health data interoperability final rule deadlines until at least January 1, 2022. Advocated for more prominent display of quality metrics on the Federal Employee Health Benefits Program plan finder.

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

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

H.R. 3, Lower Drug Costs Now Act of 2019, including provisions relating to international reference pricing H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act H.R. 2296, More Efficient Tools to Realize Information for Consumers Act H.R. 4100/S. 1712, Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2019 H.R. 4455, Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act H.R. 4597, Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars Act of 2019 H.R. 4629, Star Rating for Biosimilars Act S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act S. 1895, Lower Health Care Costs Act S. 2543, Prescription Drug Pricing Reduction Act of 2019 Issues relating to, 340B Reforms; Drug pricing; Anti-microbial Resistance; General Pharmaceutical issues transparency, formulary design, prescription drug coverage; Biosimiliars; Cost and value of medicines; Maternal Health; Vaccines; Supply chain; Coronavirus stimulus funding; HIV; Rebate pass through; Coronavirus Preparedness and response supplemental appropriations Act (P.L. 116-123); Families First Coronavirus Response Act (P.L. 116-127); Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-146).

Client expense: $2,170,000 · 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. 6074, Coronavirus Preparedness and Response Supplemental Appropriations Act. H.R. 6201, Families First Coronavirus Response Act; H.R. 748, Coronavirus Aid, Relief, and Economic Security (CARES) Act - Discussed Medicare enrollment national open enrollment period, medical expense deduction, cost-sharing protections for commercial/private health insurance holders, telehealth access, nursing homes, virtual visitation, home and community-based services, Older Americans Act programs, Medicare home health care, and family caregiving, no-cost COVID-19 testing, equitable relief payments, retirement savings tax relief, suspensions of foreclosures and evictions, expanded unemployment benefits, paid sick and family leave, affordable broadband, and government operations, among other issues. H.R. 3, Elijah E. Cummings Lower Cost Drugs Now Act. S. 2543, the Prescription Drug Pricing Reduction Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 1499 - the Preserving Consumer Access to Generics Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. H.R. 19/S. 3129, Lower Cost More Cures Act.

Client expense: $2,210,000 · Firm income: Not reported

Government targets: Administration for Children & Families (ACF), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Consumer Financial Protection Bureau (CFPB), Corporation for Natl & Community Service, Federal Deposit Insurance Corporation (FDIC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Indian Health Service, Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of the Comptroller of the Currency (OCC), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Social Security Administration (SSA), Transportation, Dept of (DOT), Treasury, Dept of, Veterans Affairs, Dept of (VA), White House Office

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,120,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office

H.R. 1781 - Payment Commission Data Act of 2019: Issues regarding providing the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to drug pricing and rebate data. H.R. 938 - Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019: Issues regarding discouraging parking of 180-day exclusivity by a first generic applicant that is blocking the approval of other generics. H.R. 1520 - Purple Book Continuity Act of 2019: Issues regarding codifying publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book; Publication and regular updating of the Purple Book electronically on the FDAs website. H.R. 1503 - Orange Book Transparency Act of 2019: Issues regarding ensuring that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019: Issues regarding brand-name and generic drug manufacturers entering into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market. H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 1385 - State Allowance for a Variety of Exchanges (SAVE) Act: Issues regarding federal funds to establish state-based Marketplaces. H.R. 1386 - Expand Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act: Issues regarding funding for Federally-Facilitated Marketplace navigator program; requirements for navigator entities in each state; Health and Human Services ensuring that navigator grants are awarded to entities with demonstrated capacity to carry out the duties specified in the Affordable Care Act. H.R. 987 - Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2019: Issues related to restoring outreach and enrollment funding to assist consumers in signing up for health care. H.R. 1010 - Issues regarding Short-Term, Limited Duration Insurance. H.R. 986 - Protecting Americans with Preexisting Conditions Act of 2019: Issues regarding rescinding Section 1332 guidance of the ACA promulgated in October 2018. H.R. 1425 - State Health Care Premium Reduction Act: Issues regarding state reinsurance program and providing financial assistance to reduce out-of-pocket costs. H.R. 820 - Public Health Service Act: Issues regarding National Institutes of Health support to collect the medical specimens and information of children with selected cancers that have the least effective treatments. H.R. 2069 - The SPIKE Act, H.R. 2113 - STAR Act, H.R. 2115 - Public Disclosure of Drug Discounts Act, H.R. 2296 - FAIR Drug Pricing Act, H.R. 2376 - Prescription Pricing for the People Act, H.R, 2757 - Creating Lower Cost Alternatives for Your Prescription Drugs Act, S. 657 - Drug Price Transparency (DPT) Act: Issues relating to drug and price transparency. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Regarding all provisions. S. 80, S. 172 - Issues regarding repeal and delay of the health insurer fee. Issues pertaining to surprise billing, including benchmark payments and arbitration models.

Client expense: $1,710,000 · Firm income: Not reported

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

H.R. 1781 - Payment Commission Data Act of 2019: Issues regarding providing the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to drug pricing and rebate data. H.R. 938 - Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019: Issues regarding discouraging parking of 180-day exclusivity by a first generic applicant that is blocking the approval of other generics. H.R. 1520 - Purple Book Continuity Act of 2019: Issues regarding codifying publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book; Publication and regular updating of the Purple Book electronically on the FDAs website. H.R. 1503 - Orange Book Transparency Act of 2019: Issues regarding ensuring that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019: Issues regarding brand-name and generic drug manufacturers entering into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market. H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 1385 - State Allowance for a Variety of Exchanges (SAVE) Act: Issues regarding federal funds to establish state-based Marketplaces. H.R. 1386 - Expand Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act: Issues regarding funding for Federally-Facilitated Marketplace navigator program; requirements for navigator entities in each state; Health and Human Services ensuring that navigator grants are awarded to entities with demonstrated capacity to carry out the duties specified in the Affordable Care Act. H.R. 987 - Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2019: Issues related to restoring outreach and enrollment funding to assist consumers in signing up for health care. H.R. 1010 - Issues regarding Short-Term, Limited Duration Insurance. H.R. 986 - Protecting Americans with Preexisting Conditions Act of 2019: Issues regarding rescinding Section 1332 guidance of the ACA promulgated in October 2018. H.R. 1425 - State Health Care Premium Reduction Act: Issues regarding state reinsurance program and providing financial assistance to reduce out-of-pocket costs. H.R. 820 - Public Health Service Act: Issues regarding National Institutes of Health support to collect the medical specimens and information of children with selected cancers that have the least effective treatments. H.R. 2069 - The SPIKE Act, H.R. 2113 - STAR Act, H.R. 2115 - Public Disclosure of Drug Discounts Act, H.R. 2296 - FAIR Drug Pricing Act, H.R. 2376 - Prescription Pricing for the People Act, H.R, 2757 - Creating Lower Cost Alternatives for Your Prescription Drugs Act, S. 657 - Drug Price Transparency (DPT) Act: Issues relating to drug and price transparency. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Regarding all provisions. S. 80, S. 172 - Issues regarding repeal and delay of the health insurer fee. Issues pertaining to surprise billing, including benchmark payments and arbitration models.

Client expense: $1,460,000 · Firm income: Not reported

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

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4244: MAGIC Act - Provisions related to FDA approval pathways H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4866: National Centers of Excellence in Continuous Pharmaceutical Manufacturing Act of 2019 - Provisions related to designation of universities as centers of excellence supporting manufacturing H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes. - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Foreign manufacturing 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 Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45) Monograph Reform, HSA/FSAs S 2740 - Over-the-Counter Monograph Safety S1872/HR5076, Protecting Seniors Through Immunization Act S1654/HR1973, Vaccine Access Improvement Act

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing S. 2740, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (Isakson) - regulations re nonprescription drugs that are marketed without an approved new drug application S. 3052, United States-Mexico-Canada Agreement Implementation Act (Grassley) - drug pricing S. 3067, Non-Opioids Prevent Addiction In the Nation Act (Capito) - non-opioid treatments S. 3092, Expanding Access to Low-Cost Generics Act of 2019 (Smith) - exclusivity period H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.R. 4640, Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 (DeFazio) - direct negotiation H.R. 4712, Fairness in Orphan Drug Exclusivity Act (Dean) - limitations on exclusive approval of orphan drugs H.R. 4810, Opioid Prescription Verification Act of 2019 (David) - dispensing of controlled substances H.R. 4906, Insulin Price Reduction Act (Diana DeGette) - insulin costs H.R. 5304, PBM Transparency in Prescription Drug Costs Act (Schrader) - PBMs H.R. 5364, End Price Gouging for Insulin Act (Beatty) - annual reference price for insulin products H.R. 5430, United States-Mexico-Canada Agreement Implementation Act (Hoyer) - drug pricing H.R. 5442, Lowest Price for Patients Act (Porter) - pharmacies to disclose any differential between the cost of a prescription drug H.R. 5444, Lower Insulin Costs Now Act (Underwood) - lowering insulin costs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,340,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Antibiotic & Diagnostic Tax Credit Biodefense Research, Development and Procurement Issues (Non-funding) ---Executive Order on Modernizing Influenza Vaccines ---Gene Editing ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Implementation of Medical Countermeasures Innovation Act ---Implementation of the 21st Century Cures Act of 2016 ---Implementation of the Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPAI) of 2019 ---National Biodefense Strategy ---Pandemic Influenza Preparedness ---Tropical Disease Priority Review Voucher (PRV) Program Biosimilars ---Access to Samples for Testing ---Biosimilar Copay Elimination ---Brazil Biologics Regulations ---Canada Biologics Regulations ---Coding ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---India Biologics Regulations ---Interchangeability and Pharmacy Substitution ---Mexico Biologics Regulations ---Naming ---Reimbursement ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 Climate Change ---RFI from House Select Committee on the Climate Crisis Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute 21st Century Cures Act 2.0 ---RFI from House Energy and Commerce Committee Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---Compassionate Use/Expanded Access ---Expedited Pathways ---FDA Hiring Flexibility ---FDA Management and Financial Accountability ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI ---Innovation Incentives ---Patient-Focused Drug Development ---Priority Review Voucher Programs ---Regulatory Reform & Modernization ---S.660: Efficiency and Transparency in Petitions Act ---Use of Real-World Evidence Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.Con.Res25: The FY 2018 Budget Resolution Drug Patenting ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 Drug Pricing ---CMMI Authority ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.2387: STOP GAMES Act of 2019 ---H.R.3199 Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---H.R.3991 Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---H.R.4398/S.1416: Affordable Prescriptions for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.2911:Seniors Prescription Drug Relief Act of 2019 Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) Funding for FDA ---Aderholt Full Committee Amendment on Germline Editing ---Biotechnology and Agriculture Trade Program ---H.R.1158: Minibus which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development appropriations bills ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 Funding for Health Resources and Services Administration (HRSA) ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.1865: Minibus which consists of the Fiscal Year 2020 Labor-Health and Human Services, Education, Defense, State-Foreign Operations, and Energy and Water Development appropriations bills Generic Drug Entry ---Access to Samples for Testing ---Generic Drug Application Review Reforms ---H.R.297: Increasing Competition in Pharmaceuticals Act of 2019 ---H.R.749: Lower Drug Costs Through Competition Act of 2018 ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.2374/S.1224: Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act of 2019 ---Incentives for Generic Drug Entry ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.660: Efficiency and Transparency in Petitions Act International Biosecurity Policies Medicaid ---Alternative payment arrangements for gene therapies ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---S.3013: Encouraging Innovative Benefit Design to Lower Costs for Seniors Act Orphan Drug Issues ---Tax Credit Reimbursement and Coverage of Innovative Products ---Administration Rebate Rule ---CMMI Authority ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.19/S.3129: Lower Costs, More Cures Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Step Therapy ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-China Trade Negotiations ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccines and Infectious Diseases ---Executive Order on Modernizing Influenza Vaccines ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Vaccine and Anti-Microbial Resistance Product Development and Incentives

Client expense: $3,120,000 · Firm income: Not reported

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

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1922: Restoring Access to Medication Act of 2019 - Provisions related to prescription drug access H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2732: Lessening Addiction By Enhancing Labeling Opioids Act of 2019 - Provisions related to labeling of prescription drugs H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4010: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug access programs H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4439: Creating Hope Reauthorization Act - Provisions related to rare disease priority review vouchers H.R. 4538: Closing Loopholes for Orphan Drugs Act - Provisions related to 340B prescription drug exclusions H.R. 4633: Investing in Safety and Innovation Act of 2019 - Provisions related to FDA programs reauthorization H.R. 4640: Affordable Pricing for Taxpayer-Funded Prescription Drugs Act of 2019 - Provisions related to prescription drug pricing and negotiation H.R. 4667: Biomedical Innovation Expansion Act of 2019 - Provisions related to NIH programs reauthorization H.R. 4710: Pharmaceutical Independence Long-Term Readiness Reform Act - Provisions related to the supply chain H.R. 4711: No Tax Breaks for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising H.R. 4812: Ensuring Compliance Against Drug Diversion Act of 2019 - Provisions related to registrations under the Controlled Substances Act H.R. 4814: Suspicious Order Identification Act of 2019 - Provisions related to reporting on distribution of controlled substances H.R. 4906: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency H.R. 4963: Stop the Importation and Manufacturing of Synthetic Analogues Act of 2019 - Provisions related to synthetic analogues H.R. 5031: Medical Innovation Act of 2019 - Provisions related to prescription drug manufacturer taxation and supplemental fees H.R. 5198: Patients' Right to Know Their Medication Act of 2019 - Provisions related to prescription drug labeling H.R. 5239: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency H.R. 5304: PBM Transparency in Prescription Drug Costs Act - Provisions related to prescription drug pricing transparency H.R. 5381: International Pharmaceutical Transparency Act of 2019 - Provisions related to prescription drug labeling H.R. 5382: To create a mechanism whereby insulin manufacturers may sell directly to consumers at current net prices - Provisions related to prescription drug pricing H.R. 5442: To amend title XXVII of the Public Health Service Act and title XVIII of the Social Security Act to require pharmacies to disclose any differential between the cost of a prescription drug based on whether certain individuals use prescription drug coverage to acquire such drug, and for other purposes - Provisions related to prescription drug pricing and transparency H.R. 5497: Conditional Approval Act - Provisions related to approval pathway S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1250: American Cures Act - Provisions related to pharmaceutical research and development S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 2004: Emergency Access to Insulin Act of 2019 - Provisions related to prescription drug pricing S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2723: Mitigating Emergency Drug Shortages Act - Provisions related to prescription drug pricing transparency and other provisions S. 2897: Patient-Centered Outcomes Research Institute Reauthorization Act - Provisions related to PCORI reauthorization Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Foreign manufacturing 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 Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) Proposed Rule; Importation of Prescription Drugs (RIN 0910-AI45)

Client expense: $6,450,000 · 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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act.

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

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

S.2543 - Prescription Drug Pricing Reduction Act of 2019 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019 H.R.447 - Affordable and Safe Prescription Drug Importation Act H.R.1922 - Restoring Access to Medication Act of 2019 H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes H.R.4633 - Investing in Safety and Innovation Act of 2019 H.R.5239 - Prescription Drug Price Reporting Act H.R.5304 - PBM Transparency in Prescription Drug Costs Act S.97 - Affordable and Safe Prescription Drug Importation Act S.657 - A bill to amend title XXVII of the Public Health Service Act to establish requirements with respect to prescription drug benefits Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Expanded access policy issues Generic drug approval process policy issues Risk Evaluation and Mitigation Strategy (REMS) policy issues PDUFA implementation policy issues 340B drug discount program policy issues Cancer drug vial size policy issues

Client expense: $620,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 1158/H.R. 1865 - The Consolidated Appropriations Act/Further Consolidated Appropriations Act. H.R. 3055/S.2584 Commerce, Justice, Science, Agriculture, Rural Development, FDA, Interior Environment, Military Construction, VA,Transportation, Housing and Urban Development Appropriations Act, FY 2020. S. 340/H.R. 965 - CREATES Act. H.R. 1499 Preserving Consumer Access to Generic Drugs Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. Discussed Part D price negotiation and out-of-pocket cap with House and Senate. Discussed proposed Anti-Kickback rule. Discussed importation. Discussed international reference pricing. Discussed H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act of 2019 and H.R. 1682, the Improving Access to Medicare Coverage Act. No bill number and H.R. 3, Elijah E. Cummings Lower Drug Costs Now Act of 2019, discussed prescription drug legislation with House staff. S.2543 the Prescription Drug Pricing Reduction Act (Grassley-Wyden bill). No bill number. Provided feedback on long-term care pharmacy bill.

Client expense: $2,140,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Pension Benefit Guaranty Corporation (PBGC), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support H.R. 965/S. 340, Creating and Restoring Equal Access to Equivalent Samples Act. Support reintroduction of Patients Access to Treatments Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support sunscreen related provisions in H.R. 269, the Pandemic & All Hazards Preparedness & Advancing Innovation Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for access to dermatological procedures for veterans through the VA MISSION Act (Public Law 115-182). Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895). Support H.R. 4575, Improving Provider Directories Act, which would require group health plans and health insurance issuers offering group or individual health insurance coverage to establish a process to address inaccurate information listed in publicly accessible provider directories of such plans and issuers. Support the Creating Opportunities Now for Necessary and Effect Care Technologies (CONNECT) for Health Act of 2019 (S. 2741/H.R. 4932), which would increase access to telehealth services.

Client expense: $340,000 · Firm income: Not reported

Government targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019; H.R. 987, Strengthening Health Care and Lowering Prescription Drug Costs Act.

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

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

H.R. 3: LOWER DRUG COSTS NOW ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 2069: SPIKE ACT; ALL PROVISIONS OF THE BILL H.R. 2296: MORE EFFICIENT TOOLS TO REALIZE INFORMATION FOR CONSUMERS ACT; ALL PROVISIONS OF THE BILL H.R. 2375: PRESERVE ACCESS TO AFFORDABLE GENERICS AND BIOSIMILARS ACT; ALL PROVISIONS OF THE BILL H.R. 2507: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 3235: ACCESS TO GENETIC COUNSELOR SERVICES ACT OF 2019; ALL PROVISIONS OF THE BILL H.R. 4439: CREATING HOPE REATHORIZATION ACT; ALL PROVISIONS OF THE BILL S. 2158: NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING THE PRESCRIPTION DRUG PRICING REDUCTION ACT'S OUTCOMES BASED AGREEMENTS GENERAL DISCUSSIONS RELATED TO PHENYLKETONURIA (PKU) LOST TO FOLLOW UP

Client expense: $160,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, U.S. Immigration & Customs Enforcement (ICE)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1922/S. 1089 _ Restoring Access to Medicine Act ___ H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency ___ H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1973: Vaccine Access Improvement Act ___ H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing ___ H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples ___ H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples ___ H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development ___ H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency ___ H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals ___ H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions ___ H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions ___ S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes ___ S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates ___ S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals ___ S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process ___ S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation ___ S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing ___ S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates ___ S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency ___ S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S.1872 _ Protecting Seniors through Immunizations Act of 2019 ___ S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing ___ Transparency policy issues ___ Drug cost and pricing policy issues ___ Drug importation and counterfeiting policy issues ___ HHS Safe Importation Action Plan ___ 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 ___ Cancer drug vial size policy issues ___ TRICARE pharmacy pilot program ___ Drug shortages policy issues ___ Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $1,360,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan 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 Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $6,230,000 · 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), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), President of the U.S., SENATE, U.S. Trade Representative (USTR)

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting S. 2247, Phair Relief Act of 2019 (Kennedy)-transparency around price concessions for drugs S. 2387, We Protect American Investment in Drugs Act (Van Hollen)-drug pricing S. 2543, Prescription Drug Pricing Reduction Act of 2019 (Grassley)-Drug pricing H.R. 3, Lower Drug Costs Now Act of 2019 (Pallone)-drug pricing H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products H.R. 3805, Prescription Drug Rebate Reform Act of 2019 (Gallagher)- drug rebates H.R. 3927, PDMPs Help Patients Act of 2019 (McKinley)-integrating SUDs and behavioral health into PDMPs H.R. 3947, Competition Prescription Act of 2019 (Meadows)- drug pricing H.R. 4010, Emergency Access to Insulin Act of 2019 (Craig)- drug pricing H.R. 4106, Responsibility in Drug Advertising Act of 2019 (DeLauro)-transparency in drug pricing H.R. 4244, MAGIC Act (Kelly)-pathways for insulin approval H.R. 4398, Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (Cicilline)-drug pricing H.R. 4455, BIOSIM Act (Schrader)-access to biosimilars H.R. 4460, Turn the Tide Act (Kuster)-Opioids H.R. 4538, Closing Loopholes for Orphan Drugs Act (Welch)-Access to drugs H.Con.Res. 55, Expressing the sense of Congress on the need to inform American consumers with more balanced purchasing information for prescription drugs through the disclosure of price information in direct-to-consumer (DTC) advertisements. (Burgess)-drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,110,000 · 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), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), Treasury, Dept of, White House Office

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---340B Optimization Act (Discussion Draft House/Senate) ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Program Implementation & Oversight Access to Medicines/World Health Organization Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Biosimilars ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Access to Samples for Testing ---Patient Cost-Sharing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Interchangeability and Pharmacy Substitution ---Medicare Reimbursement ---Naming ---Biosimilar Copay Elimination Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 Drug Manufacturing, Quality & Distribution ---S.551 REFUND Act of 2019 ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Drug Pricing ---General ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416/H.R. 4398 : Affordable Prescriptions for Patients Act of 2019 ---H.R.3991: Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---S.2543: Prescription Drug Pricing Reduction Act of 2019 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---International Reference Pricing ---Administration International Pricing Index Proposal ---Direct Government Negotiation/Price Setting/Arbitration/Compulsory Licensing ---Medicare Part D Prescription Drug Program ---Medicare Part B Prescription Drug Program ---Value-based Contracting ---Rebate reform Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163/S.2520: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164/S.2522: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Generic Drug Entry ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---Access to Samples for Testing ---Incentives for Generic Drug Entry Medicaid ---H.R.3: Lower Drug Costs Now Act of 2019 ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Arrangements Medicare Expansion ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research ---H.R.5590: Opioid Addiction Action Plan Act ---Transparency Orphan Drug Issues ---Tax Credit Precision Medicine Initiative ---Genome Editing Reimbursement and Coverage of Innovative Products ---H.R.3: Lower Drug Costs Now Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Adult Immunization Education ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,080,000 · 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), Justice, Dept of (DOJ), Natl Economic Council (NEC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Trade Representative (USTR), White House Office

Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 1959, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077/S. 2546, Safe Step Act. Support H.R. 1035, Prescription Drug Price Transparency Act. Support H.R. 985, Fair Access for Safe and Timely Generics Act. Support H.R. 965/S. 340, Creating and Restoring Equal Access to Equivalent Samples Act. Support reintroduction of Patients Access to Treatments Act. Support S. 476, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 1034/S. 640, Phair Pricing Act. Support S. 657, Drug Price Transparency Act Support H.R. 938, BLOCKING Act Support H.R. 2375/S. 64, Preserve Access to Affordable Generics & Biosimilars Act Support H.R. 1499, Protecting Consumer Access to Generic Drugs Act Support H.R. 2296/S. 1391, Fair Accountability & Innovative Research (FAIR) Drug Pricing Act Support H.R. 2069, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act. Support H.R. 2115, Public Disclosure of Drug Discounts Act Support H.R. 2376/S. 1227, Prescription Pricing for the People Act Support H.R. 1379/S. 560, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 3107, Seniors Timely Access to Care Act Support sunscreen related provisions in H.R. 269, the Pandemic & All Hazards Preparedness & Advancing Innovation Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Support S. 2443 Investment in Tomorrows Pediatric Health Care Workforce Act Support H.R. 1554, Resident Education Deferred Interest (REDI) Act. Advocate for access to dermatological procedures for veterans through the VA MISSION Act (Public Law 115-182). Advocate for the continued and increased funding of Community Health Centers. Lobby members of Congress to cosponsor H. Res. 323, which would support state, local, and community initiatives to encourage parents, teachers, camp counselors, and childcare professionals to take measures to prevent sunburns in the minors they care for, and would express the sense of the House of Representatives that state, local, and community entities should continue to support efforts to curb the incidences of skin cancer beginning with childhood skin protection. In the context of legislation to address surprise medical bills, advocate for an independent dispute resolution (IDR) process to resolve disputes between payers and physicians and against provisions that would set out-of-network reimbursement rates at a benchmark level. (H.R. 2328, H.R. 3502, S. 1531, S. 1895)

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

Government targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE

S.2543 - Prescription Drug Pricing Reduction Act of 2019 HR 3 H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 HR 938: Bringing Low-Cost Options and Competition while Keeping Incentives for New Generics Act HR 1520: Purple Book Continuity Act HR 1503: Orange Book Transparency Act HR 1499: Protecting Consumer Access to Generic Drugs Act HR 2113:Speeding Access to Already Approved Pharmaceuticals Act of 2017 HR 5997:Ensuring Patient Access to Critical Breakthrough Products Act of 2018 Senate SPIKE Act Fast Generics Cell & Gene Therapy, including reimbursement 340B Drug Discount Program Drug Importation REMS Creates Act Drug Cost/Pricing Biosimilars Reimbursement Outcomes based Contracting Part D Non-interference Orphan Drugs Drug Pricing Transparency Virtual Clinical Trials Part D Benefit Redesign Biosimilar Pass Through Payments Value Based Pricing USMCA Medicaid Payment Reform AMP Cap Labor HHS Appropriations S 1895 - Lower Health Care Costs Act HR 987 - Strengthening Health Care and Lowering Prescription Drug Costs Act H.R.478 - Safe and Affordable Drugs from Canada Act of 2019 H.R.965 - CREATES Act of 2019 H.R.985 - FAST Generics Act of 2019 H.R.1093 - Stop Price Gouging Act H.R.1332 - Fair Care Act of 2019 H.R.1506 - FAIR Generics Act H.R.2011 - Protecting Access to Biosimilars Act of 2019 H.R.2069 - SPIKE Act H.R.2087 - Drug Price Transparency Act H.R.2113 - Prescription Drug STAR Act H.R.2296 - FAIR Drug Pricing Act of 2019 H.R.3327 - Drug Price Transparency for Medicare Patients Act of 2019 H.R.3408 - EXEMPT Act S.61 - Safe and Affordable Drugs from Canada Act of 2019 S.340 - CREATES Act of 2019 S.474 - Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 S.1140 - Protecting Access to Biosimilars Act of 2019 S.1384 - Prescription Drug Rebate Reform Act of 2019 S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 S.1437 - Drug-price Transparency in Communications (DTC) Act S.1224 - Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Stop STALLING Act) S.1227 - Prescription Pricing for the People Act of 2019

Client expense: $1,140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), White House Office

H.R. 3055/S.2584 Commerce, Justice, Science, Agriculture, Rural Development, FDA, Interior Environment, Military Construction, VA,Transportation, Housing and Urban Development Appropriations Act, FY 2020. Discussed H.R. 3, the Lower Drug Costs Now Act of 2019 and S. 2543, Prescription Drug Pricing Reduction Act and lowering prescription drug prices. H.R. 3164 Agriculture-Rural Development Appropriations bill, FY 2020- lobbied to protect funding for FDA drug processing funding and user fees. Discussed Medicare Part D issues including part D price negotiation and Part D out-of-pocket cap. S. 340/H.R. 965 - CREATES Act. H.R. 1499 Preserving Consumer Access to Generic Drugs Act. S.64/H.R. 2375 - the Preserve Access to Generics and Biosimilars Act. H.R. 2113 - the Prescription STAR Act. H.R. 2296/S.1391 - The FAIR Drug Pricing Act. S.1416 - the Affordable Prescriptions for Patients Act. S.1437, the Drug-price Transparency in Communications (DTC) Act. S.551, the REFUND Act. S.1209, the REMEDY Act. S. 474/H.R. 2069, the SPIKE Act. H.R. 3 - The Lower Drug Costs Now Act. S. 2543- the Prescription Drug Pricing Reduction Act. Lobbied Senate in support. Discussed proposed Anti-Kickback rule. Discussed Rx importation. Discussed international reference pricing for Rx.

Client expense: $2,140,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Housing & Urban Development, Dept of (HUD), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Securities & Exchange Commission (SEC), Transportation, Dept of (DOT), Treasury, Dept of, White House Office

H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing 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 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: $6,310,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

P.L. 111-148, Patient Protection and Affordable Care Act - provisions related to PCORI reauthorization; S. 1379, H.R. 269, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; Proposals related to drug pricing, including House and Senate draft bills; H.R. 465, S. 102, The Prescription Drug Price Relief Act of 2019 - provisions related to foreign reference pricing, patents and march-in rights; S. 97, H.R. 447, The Affordable and Safe Prescription Drug Importation Act - provisions related to importation; S. 205, The Right Rebate Act of 2019 -provisions related to Medicaid drug rebates and drug classification; H.R. 938, The Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) - provisions related to 180 day generic prescription drug exclusivity; H.R. 1188, S. 366, FLAT Prices Act - provisions related to prescription drug exclusivity periods and pricing; S. 340, H.R. 965, The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act - provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems; H.R. 1034, Phair Pricing Act of 2019 - provisions related to Part D and manufacturer rebates; H.R. 1035; Prescription Drug Price Transparency Act - provisions related to drug pricing transparency and pharmacy benefit managers; S. 73, End Taxpayer Subsidies for Drug Ads Act - provisions related to direct-to-consumer prescription drug advertising; S. 657, Drug Price Transparency Act - provisions related to prescription drug pricing transparency and commercial market rebates; H.R. 2279, Safe Step Act - provisions related to step therapy policy; Patient Affordability Value and Efficiency Act (Not Yet Introduced) - to amend titles XI, XVIII, and XIX of the Social Security Act to promote value-based arrangements; S. 2004, Emergency Access to Insulin Act of 2019 - provisions related to biologics exclusivity; Discussions related to amending P.L. 97-414, Orphan Drug Act; H.R. 2375, S. 64, Preserve Access to Affordable Generics and Biosimilars Act - provisions related to patent settlements; H.R. 937, Right Rebate Act of 2019 - provisions related to Medicaid drug rebates and drug classification; S. 659, Biologic Patent Transparency Act - provisions related to prescription drug patent disclosures; H.R. 2069, S. 474, Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 - provisions related to increases in the wholesale acquisition costs of prescription drugs; S. 977, Transparent Drug Pricing Act of 2019 - provisions related to transparency and drug pricing; S.1140, Protecting Access to Biosimilars Act of 2019 - provisions related to biological products; H.R. 2296, S. 1391, FAIR Drug Pricing Act of 2019 - provisions related to prescription drug pricing and transparency; H.R. 2455, S. 1169, Ensuring Timely Access to Generics Act of 2019 - provisions related to citizen petitions; S. 1416, Affordable Prescriptions for Patients Act of 2019 - provisions related to prescription drug patents; H.R. 3276, S. 1785, Fair AMP Act - provisions related to AMP cap, exclusion of authorized generics from AMP; Bayh-Dole march-in rights policy issues; S. 3, Keeping Health Insurance Affordable Act - provisions related to prescription drug pricing;

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of

S. 61, Safe and Affordable Drugs from Canada Act (Grassley) - drug importation S. 64, Preserve Access to Affordable Generics and Biosimilars Act (Grassley-Klobuchar) - prohibiting pay-for-delay settlements S. 73, End Taxpayer Subsidies for Drug Ads Act (Shaheen) - prohibiting tax deduction for DTC advertising expenses S. 102, Prescription Drug Price Relief Act (Sanders) - reforms linked to international pricing S. 340, CREATES Act (Leahy) - removing barriers to generic drugs S. 344, Hatch-Waxman Integrity Act (Tillis) - inter partes review process S. 366, FLAT Prices Act (Durbin) - reforms for drugs with sudden price spikes S. 378, Stop Price Gouging Act (Durbin) - excise tax for drugs that have price spikes S. 440, Preserving Access to Cost-Effective Drugs Act (Cotton) - sovereign immunity and Inter Partes Review process S. 474, SPIKE Act (Wyden) - justification for drug price increases S. 476, Creating Transparency to Have Drug Rebates Unlocked Act (Wyden) - drug price transparency S. 637, CURE High Drug Prices Act (Blumenthal) - remedies for price gouging S. 657, Point of Sale Rebates (Braun) S. 659, Biologic Patent Transparency Act (Collins) - patent disclosure requirements S. 660, Efficiency and Transparency in Petitions Act (Braun) - FDA citizen petition process S. 844, Short on Competition Act (Klobuchar) - remedies for marginally competitive drug markets S. 977, Transparency Drug Pricing Act (Scott) - transparency and drug pricing reforms S. 1209, Reforming Evergreening and Manipulation that Extends Drug Years Act (Cassidy) - preventing evergreening of patent protections S. 1224, Stop STALLING Act (Klobuchar) - citizen petition process S. 1227, Prescription Pricing for the People Act (Grassley) - FTC report on role of PBMs and allegations of anticompetitive conduct by manufacturers of sole-source drugs S. 1384, Prescription Drug Rebate Reform Act (Romney-Braun) - prescription drug cost sharing S. 1416, Affordable Prescriptions for Patients Act (Cornyn) - product hopping, patent thickets S. 1664, Prescription Drug Price Reporting Act (Scott) - prescription drug price reporting H.R. 465, Prescription Drug Price Relief Act (Khanna) - reforms linked to international pricing H.R. 478, Safe and Affordable Drugs from Canada Act (Pingree) - drug importation H.R. 938, BLOCKING Act (Schrader) - changes to 180-day period of market exclusivity for first generic applicant H.R. 965, CREATES Act (Cicilline) - removing barriers to generic drugs H.R. 985, FAST Generics Act (Welch) - removing barriers to generic drugs H.R. 990, Hatch-Waxman Integrity Act (Flores) - inter partes review process H.R. 1093, Stop Price Gouging Act (Pocan) - excise tax for drugs that have price spikes H.R. 1188, FLAT Prices Act (Golden) - reforms for drugs with sudden price spikes H.R. 1344, Competitive DRUGS Act (Doggett) - prohibiting pay-for-delay agreements H.R. 1419, Public Option Deficit Reduction Act (DeFazio) - public option H.R. 1499, Protecting Consumer Access to Generic Drugs Act (Rush) - prohibiting pay-for-delay agreements H.R. 1503, Orange Book Transparency Act (Kelly) - removal of invalidated patents from Orange Book H.R. 1506, FAIR Generics Act (Barragan) - changes to 180-day period of market exclusivity for first generic applicant H.R. 1520, Purple Book Continuity Act (Eshoo) - access to updated information on biologics and biosimilars H.R. 2038, State-Based, Market-Oriented Prescription Drug Negotiations Act (Meadows) - drug price negotiations H.R. 2064, Sunshine for Samples Act (Chu) - reporting requirements on drug samples H.R. 2069, SPIKE Act (Horsford) -justification for drug price increases H.R. 2087, Drug Price Transparency Act (Doggett) - reporting of drug pricing data under Medicare Part B H.R. 2113, Prescription Drug Sunshine, Transparency, Accountability and Reporting Act (Neal) - transparency in drug pricing H.R. 2115, Public Disclosure of Drug Discounts Act (Spanberger) - disclosure of negotiated Rx discounts H.R. 2279, Safe Step Act (Ruiz) - exceptions process for medication step therapy H.R. 2296, FAIR Drug Pricing Act (Schakowsky) - transparency requirements and justification for high list prices and drug price increases H.R. 2374, Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act (Jeffries) - citizen petition process H.R. 2375, Preserve Access to Affordable Generics and Biosimilars Act (Nadler) - prohibiting pay-for-delay agreements H.R. 2376, Prescription Pricing for the People Act (Collins) - FTC study on role of PBMs and competition and transparency in pharmaceutical supply chain H.R. 3379, Price Relief, Innovation, and Competition for Essential Drugs Act (Schakowsky) - exclusivity period for biological products Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $2,210,000 · 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), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 1922: Restoring Access to Medicine Act H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S.12: Health Savings Account of 2019 S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S.182: Protecting Seniors through Immunization Act S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S.1654/H.R. 1973: Vaccine Access Improvement Act S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization 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: $870,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 1781, Payment Commission Data Act; H.R. 1503, Orange Book Transparency Act of 2019; H.R. 1520, Purple Book Continuity Act of 2019; H.R. 965 and S. 340, the CREATES Act; H.R. 2113, Prescription Drug STAR Act of 2019; H.R. 2069/S. 474, Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019; H.R. 2296/S. 1391, FAIR Drug Pricing Act of 2019; S. 1895, Lower Health Care Costs Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers (METRIC) Act of 2019.

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

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

340B Drug Discount Program ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---340B Optimization Act (Discussion Draft House/Senate) ---340B Pause Act (Discussion Draft House/Senate) ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Program Implementation & Oversight Access to Medicines/World Health Organization Biodefense Research, Development and Procurement Issues (Non-funding) ---H.R.269/S.1379: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 ---Gene Editing ---National Biodefense Strategy ---Pandemic Influenza Preparedness Biosimilars ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.659: Biologic Patent Transparency Act of 2019 ---Access to Samples for Testing ---Patient Cost-Sharing ---Implementation and Reauthorization of the Biosimilar User Fee Act of 2017 ---Interchangeability and Pharmacy Substitution ---Medicare Reimbursement ---Naming Comparative Effectiveness Research Initiatives ---Reauthorization of Patient-Centered Outcomes Research Institute Diagnostics and Personalized Medicine Regulation and Oversight ---VALID Act (Discussion Draft House) Drug Evaluation and Review ---FDA Review of CBD-Based Drugs ---Implementation of the Prescription Drug User Fee Act (PDUFA) VI Drug Importation ---General ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ---S.97: Affordable and Safe Prescription Drug Importation Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Drug Manufacturing, Quality & Distribution ---S.551 REFUND Act of 2019 ---Counterfeiting ---Drug Shortages ---Pharmacy Compounding & Oversight Drug Patenting ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---H.R.1520: Purple Book Continuity Act of 2019 ---H.R.3199: Terminating the Extension of Rights Misappropriated (TERM) Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1617: Second Look at Drug Patents Act of 2019 ---S.1895: Lower Health Care Costs Act of 2019 Drug Pricing ---General ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---H.R.1046/S.377: Medicare Negotiation and Competitive Licensing Act of 2019 ---H.R.1093/S.378: Stop Price Gouging Act of 2019 ---H.R.1188/S.366: Forcing Limits on Abusive and Tumultuous Prices (FLAT) Prices Act of 2019 ---H.R.2069/S.474: Stopping the Pharmaceutical Industry from Keeping drugs Expensive (SPIKE) Act of 2019 ---H.R.2376/S.1227: Prescription Pricing for the People Act of 2019 ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.2113: Prescription Drug STAR Act of 2019 ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.476: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---S.844: Short on Competition Act of 2019 ---S.1416: Affordable Prescriptions for Patients Act of 2019 ---S.1895: Lower Health Care Costs for Patients Act of 2019 ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Pricing Transparency Foreign Drug Data Protection Laws ---China ---Saudi Arabia Funding for Antimicrobial Resistance Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for FDA ---H.R.3055: Consolidated Appropriations Act of 2019 (which consists of FY 2020 Commerce-Justice-Science, Agriculture-Rural Development-FDA, Interior-Environment, Military Construction-Veterans Affairs, and Transportation-Housing and Urban Development Appropriations Bills) ---H.R.3163: Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 ---H.R.3164: Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 ------Aderholt Full Committee Amendment on Germline Editing ---Agriculture, Rural Development, FDA, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---Transportation, and Housing and Urban Development, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for Health Resources and Services Administration (HRSA) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) ---340B Program Integrity Issues ---Vaccine Injury Compensation Program (VICP) Funding for National Institutes of Health ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the Centers for Disease Control and Prevention Vaccine Programs ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Funding for the National Vaccine Program Office (NVPO) ---H.R.2740: Consolidated Appropriations Act of 2019 (which consists of the FY 2020 Labor-Health and Human Services-Education, Defense, State-Foreign Operations, and Energy-Water Development Appropriations Bills) ---H.R.2740: Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 ---Labor, Health and Human Services, Education, and Related Agencies Appropriations Act for FY 2020 (Discussion Draft Senate) Generic Drug Entry ---H.R.938: Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019 ---H.R.965/S.340: CREATES Act of 2019 ---H.R.1499: Protecting Consumer Access to Generic Drugs Act of 2019 ---H.R.1503: Orange Book Transparency Act of 2019 ---S.64: Preserve Access to Affordable Generics and Biosimilars Act of 2019 ---Access to Samples for Testing ---Incentives for Generic Drug Entry Medicaid ---Average Manufacturer Price Calculations ---Drug Benefit Design ---Pricing and Rebates ---Value-Based Arrangements Medicare Expansion ---S.1129: A bill to establish a Medicare-for-all national health insurance program of 2019 Opioid Crisis ---Coverage and Reimbursement ---FDA Reforms ---Implementation of the SUPPORT for Patients and Communities Act of 2018 ---NIH Research Orphan Drug Issues ---Tax Credit Precision Medicine Initiative ---Genome Editing Reimbursement and Coverage of Innovative Products ---H.R.275: Medicare Prescription Drug Price Negotiation Act of 2019 ---H.R.488/S.99: Medicare Drug Price Negotiation Act of 2019 ---S.62: Empowering Medicare Seniors to Negotiate Drug Prices Act of 2019 ---S.771: Improving Access to Affordable Prescription Drugs Act of 2019 ---Administration Rebate Rule ---CMMI Authority ---HHS Blueprint to lower drug prices and reduce out of pocket costs ---International Pricing Index Proposal ---Medicare Part B Physician-Administered Products ---Medicare Part D Prescription Drug Program ---Patient Cost-Sharing ---Protected Classes ---Step Therapy ---Third Party Support of Patient Premiums and Cost-Sharing Obligations ---Value-based Contracting and Communications The United States-Mexico-Canada Agreement ---IP Provisions US-Japan Trade Agreement ---IP Provisions Vaccine Injury Compensation Tax ---H.R.1973/S.1654: Vaccine Access Improvement Act of 2019 Vaccines and Infectious Diseases ---H.R.2862/S.1619: Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019 ---S.1872: Protecting Seniors through Immunizations Act of 2019 ---Adult Immunization Education ---Vaccine and Anti-Microbial Resistance Product Development and Incentives ---Vaccine Injury Compensation Program

Client expense: $3,010,000 · 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 Institutes of Health (NIH), 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

Education on the importance of maintaining the competitive elements of the Part D prescription drug program and to oppose efforts to impose mandatory government rebates in that program and concerns about beneficiary out of pocket costs. H.R.107: 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.2113: Prescription Drug STAR Act. H.R.2069: SPIKE Act. H.R.2296: FAIR Drug Pricing Act of 2019. Regulatory and legislative proposals in the Administrations Drug Pricing Blueprint. CMS rule dealing with Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES

H.R. 1781 - Payment Commission Data Act of 2019: Issues regarding providing the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to drug pricing and rebate data. H.R. 938 - Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019: Issues regarding discouraging parking of 180-day exclusivity by a first generic applicant that is blocking the approval of other generics. H.R. 1520 - Purple Book Continuity Act of 2019: Issues regarding codifying publication of the patents of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book; Publication and regular updating of the Purple Book electronically on the FDAs website. H.R. 1503 - Orange Book Transparency Act of 2019: Issues regarding ensuring that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. H.R. 1499 - Protecting Consumer Access to Generic Drugs Act of 2019: Issues regarding brand-name and generic drug manufacturers entering into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market. H.R. 965, S. 340 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019: Issues regarding processes by which generic manufacturers can obtain sufficient quantities of brand drug samples for testing. H.R. 1385 - State Allowance for a Variety of Exchanges (SAVE) Act: Issues regarding federal funds to establish state-based Marketplaces. H.R. 1386 - Expand Navigators Resources for Outreach, Learning, and Longevity (ENROLL) Act: Issues regarding funding for Federally-Facilitated Marketplace navigator program; requirements for navigator entities in each state; Health and Human Services ensuring that navigator grants are awarded to entities with demonstrated capacity to carry out the duties specified in the Affordable Care Act. H.R. 987 - Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2019: Issues related to restoring outreach and enrollment funding to assist consumers in signing up for health care. H.R. 1010 - Issues regarding Short-Term, Limited Duration Insurance. H.R. 986 - Protecting Americans with Preexisting Conditions Act of 2019: Issues regarding rescinding Section 1332 guidance of the ACA promulgated in October 2018. H.R. 1425 - State Health Care Premium Reduction Act: Issues regarding state reinsurance program and providing financial assistance to reduce out-of-pocket costs. H.R. 820 - Public Health Service Act: Issues regarding National Institutes of Health support to collect the medical specimens and information of children with selected cancers that have the least effective treatments. H.R. 2069 - The SPIKE Act, H.R. 2113 - STAR Act, H.R. 2115 - Public Disclosure of Drug Discounts Act, H.R. 2296 - FAIR Drug Pricing Act, H.R. 2376 - Prescription Pricing for the People Act, H.R, 2757 - Creating Lower Cost Alternatives for Your Prescription Drugs Act, S. 657 - Drug Price Transparency (DPT) Act: Issues relating to drug and price transparency. H.R. 3253 - Empowering Beneficiaries, Ensuring Access, and Strengthening Accountability Act of 2019: Regarding all provisions. S. 1895 - The Lower Health Care Costs Act: Regarding all provisions. S. 80, S. 172 - Issues regarding repeal and delay of the health insurer fee. Issues pertaining to surprise billing, including benchmark payments and arbitration models.

Client expense: $1,430,000 · Firm income: Not reported

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