Increasing Competition in Pharmaceuticals Act

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Drug Shortages. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. S.3792: Preserve Access to Affordable Generics and Biosimilars Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Pharmaceutical Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. H.R.7348/S.3775: Affordable Drug Manufacturing Act of 2018. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. S.3680: Low Drug Prices Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. H.R.6: SUPPORT for Patients and Communities Act.

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

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

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

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

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

Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. 340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392 and H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Drug Shortages - Engaged in discussions around how ongoing shortages of prescription drugs are impacting hospitals and possible solutions. Advocated for the Drug Enforcement Agency to modify total annual production quotas to address hospital shortage of injectable opioid solutions. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Supported H.R. 6082. Children's Hospital GME Support Reauthorization Act (H.R.5385, S.2597) - Endorsed passage of legislation to reauthorize the Children's Hospital GME program. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.

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

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

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes Monitored HR 6 SUPPORT for Patients and Communities Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $870,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $900,000 · Firm income: Not reported

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

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $1,040,000 · Firm income: Not reported

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

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $656,680 · Firm income: Not reported

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

Legislation and policies related to: Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 6 - Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R. 749 - Lower Drug Costs through Competition Act H.R. 3692/S. 2317 - Addiction Treatment Access Improvement Act S. 204/H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 297 - Increasing Competition in Pharmaceuticals Act S. 771/H.R. 1776 - Improving Access to Affordable Prescription Drugs Act S. 892 - Opioid Addiction Prevention Act of 2017 S. 2456 - CARA 2.0 Act of 2018 S. 2680 - Opioid Crisis Response Act of 2018

Client expense: Not reported · Firm income: $23,450

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. S.3519: MODERN Labeling Act. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. H.R.6577: PRICED Act. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, Packaging and Disposal. H.R.6: SUPPORT for Patients and Communities Act.

Client expense: $860,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Monitored HR6 SUPPORT for Patients and Communities Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related to Medicare rebate disclosure; issues related to S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018"; issues related to S. 297 "Increasing Competition in Pharmaceuticals Act"; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"

Client expense: $760,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

Client expense: $1,510,000 · Firm income: Not reported

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

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

Client expense: $1,500,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of

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

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Discussions pertinent to health care group purchasing organizations (GPOs) role in helping to prevent drug shortages Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2018 (proposed Alexander-Murray legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes Monitored HR 6 SUPPORT for Patients and Communities Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B Drug Pricing Program - Opposed changes to eligibility and the structure of the 340B Drug Pricing Program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Biosimilar Drug adoption - Supported administrative proposals that would expand the adoption of biosimilar medications. Urged the Food and Drug Administration to finalize guidance related biosimilar interchangeability. Opioid Abuse - Supported passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Supported changes to privacy requirements under 42 CFR Part 2 to better support coordinated care for patients. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements.

Client expense: $155,000 · Firm income: Not reported

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

H.R.6127/S.3159 - Department of Defense Appropriations Act, 2019 H.R.5515/S.297 - National Defense Authorization Act for Fiscal Year 2019

Client expense: $600,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H. Res. 142/S. Res. 63 National Obesity Care Week Resolution S. Res. 325 National Obesity Care Week Resolution S. J. Res. 16 a joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the independent payment Medicare advisory board H.J. Res 51/S. J. Res 17 Independent Payment Advisory Board Repeal H.R 1995 Value Based Insurance Design for Better Care Act H.R. 1004 Regulatory Integrity Act H.R. 1009/S. 676 OIRA Insight, Reform, and Accountability Act H.R. 1038/S. 413 Improving Transparency and Accuracy in Medicare Part D Spending H.R. 1072/S. 222 Obamacare Replacement Act H.R. 1101 Small Business Health Fairness Act H.R. 1121 Pre-Existing Conditions Protection Act H.R. 1148/S. 431 Furthering Access to Stroke Telemedicine (FAST) Act H.R. 1215 Protecting Access to Care Act H.R. 1267/S. 482 Personal Health Investment Today Act H.R. 1304 Self-Insurance Protection Act H.R. 1313 Preserving Employee Wellness Programs Act H.R. 1554 Jessie's Law H.R. 1565 Saving Lives, Saving Costs Act H.R. 1628 American Health Care Act H.R. 1703 Medical Product Communications Act H.R. 184 Protect Medical Innovation Act H.R. 1953/S. 830 Treat and Reduce Obesity Act H.R. 2267/S. 1301 Resident Physician Shortage Reduction Act H.R. 246/S. 183 Jobs and Premium Protection Act H.R. 2550 Medicare Telehealth Parity Act H.R. 2556/S. 1016 CONNECT for Health Act H.R. 2797/S. 1334 Patient Choice and Quality Care Act H.R. 2824 Increasing Opportunity and Success for Children and Parents Through Evidence-Based Home Visiting Act H.R. 284 Advancing Medical Resident Training in Community Hospitals Act H.R. 2953/S. 2164 Preventive Health Savings Act H.R. 3044 to expand supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees H.R. 3059/S. 1441 Community Health Center and Primary Care Workforce Expansion Act H.R. 3120 to reduce the volume of future electronic health record-related significant hardship requests H.R. 3124/S. 1299 Preventing Diabetes in Medicare Act H.R. 3168 to provide continued access to Medicare Advantage plans for special needs H.R. 3224 Critical Access and Rural Equity Act H.R. 3245 Medicare Civil and Criminal Penalties Act H.R. 3263 to extend the Medicare independence at home medical demonstration program H.R. 3358/S. 1771 Fiscal Year 2018 Labor-Health and Human Services-Education Appropriations Bill H.R. 3394 Teaching Health Centers Graduate Medical Education Extension Act H.R. 3447 Furthering Access to Coordinated Treatment for Seniors Act H.R. 3545 Overdoes Prevention and Patient Safety Act H.R. 3726 Stark Administrative Simplification Act of 2017 H.R. 3728 Empowering Medical Professionals and Optimizing Workforce Efficiency and Readiness Act H.R. 3820/S. 977 Medicare Home Health Flexibility Act H.R. 3862 National Health Service Corps Strengthening Act H.R. 3921 Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act H.R. 3922 Continuing Community Health and Medical Professional Programs to Improve Our Nation, Increase National Gains, and Help Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act H.R. 4541 Continuing Community Health and Medical Professional Programs to Improve Our Nation and Keep Insurance Delivery Stable H.R. 4613 Ensuring Patient Access to Healthcare Records Act H.R. 4616 to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617 to provide for a temporary moratorium on the medical device excise tax H.R. 4618 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619 to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620 Protecting Families and Small Businesses Act H.R. 4006 Community-Based Independence for Seniors Act of 2017 H.R. 4200/S. 2052 Healthcare Market Certainty and Mandate Relief Act H.R. 4520 to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2017 H.R. 4552/S. 1291 Advancing Medical Training in Community Hospitals Act H.R. 4105 to extend the health professions workforce demonstration project H.R. 592/S. 109 Pharmacy and Medically Underserved Areas Enhancement Act H.R. 706 Plan Verification and Fairness Act H.R. 741/S. 243 Rural Hospital Regulatory Relief Act H.R. 749 Lower Drug Costs Through Competition Act H.R. 766 Amend Title XVII of the Social Security Act to expand telehealth in Medicare H.R. 849/S. 260 Protecting Seniors' Access to Medicare Act H.R. 908 Medicare Advantage Quality Payment Relief Act H.R. 998 Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act H.R.3545 Overdose Prevention and Patient Safety Act H.R.3727 To amend title XVIII of the Social Security Act to include additional telehealth services for purposes of MA organization bids, and for other purposes H.R. 4206/S. 2051 Medicare Care Coordination Improvement Act Introduction of the Healthcare Cybersecurity Improvement Act Introduction of the Stark Law Modernization Act of 2017 Pub L. 114-198 Comprehensive Addiction and Recovery Act Pub L. 115-31 Fiscal Year 2017 Consolidated Appropriations Act Pub L. 115-80 National Clinical Care Commission Act Pub. L. 102-143 Telephone Consumer Protection Act Pub. L. 111-148 Patient Protection and Affordable Care Act (PPACA) Pub. L. 111-5 The American Recovery and Reinvestment Act Pub. L. 114-10 Medicare Access and CHIP Reauthorization Act (MACRA) Pub. L. 114-255, 21st Century Cures Act Pub. L. 114-270 Expanding Capacity for Health Outcomes Act (ECHO) Pub. L. 114-328 National Defense Authorization Act for Fiscal Year Pub. L. 114-329 American Innovation and Competitiveness Act Pub L. 115-63 Disaster Relief and Airway Extension Act Pub. L. 115-96 2018 Continuing Resolution Pub. L. 115-97 Tax Cuts and Jobs Act Reintroduction of TELE-MED Act of 2015 S. 108 Medical Device Access and Innovation Protection Act S. 297 Increasing Competition in Pharmaceuticals Act S. 1754 Training the Next Generation of Primary Care Doctors Act S. 1827 Keep Kids' Insurance Dependable and Secure Act S. 1829 Strong Families Act S. 1850 Protecting Jessica Grubbs Legacy Act (The Legacy Act) S. 1859 Healthcare Tax Relief Act S. 1899 to reauthorize and extend funding for community health centers and the National Health Service Corps S. 1967 Mandate Relief Act S. 191 Patient Freedom Act S. 251 Protecting Medicare from Executive Action Act S. 309 Community Based Independence for Seniors Act S. 464 Independence at Home Act H .R. 1933/S. 761 Health Care Options Act of 2017 S. 787 Telehealth Innovation and Improvement Act S. 870 Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act S. 1978 Small Business and Family Health Tax Relief Act S. Con. Res. 3 Budget Resolution

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

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

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislation and policies related to: Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 6 - Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act H.R. 749 - Lower Drug Costs through Competition Act H.R. 3692/S. 2317 - Addiction Treatment Access Improvement Act S. 204/H.R. 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 297 - Increasing Competition in Pharmaceuticals Act S. 771/H.R. 1776 - Improving Access to Affordable Prescription Drugs Act S. 892 - Opioid Addiction Prevention Act of 2017 S. 2456 - CARA 2.0 Act of 2018 S. 2680 - Opioid Crisis Response Act of 2018

Client expense: Not reported · Firm income: $23,450

Government targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Homeland Security, Dept of (DHS), Housing & Urban Development, Dept of (HUD), Justice, Dept of (DOJ), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Reauthorization Act (FDARA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. American Patients First: The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.449: Synthetic Drug Awareness Act of 2018. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. Public Law 115-123: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.5002: Advancing Cutting Edge Research Act. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. Public Law 115-52: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $800,000 · Firm income: Not reported

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

340B Drug Pricing Program - Highlighted importance of the 340B Drug Pricing program for safety net hospitals and monitored ongoing discussions around reforming the program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Shortages - Advocated for Drug Enforcement Agency to modify total production quotas for injectable opioid solutions to address hospital shortages. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). Opioid Abuse - Supported House passage of H.R. 6 and ongoing efforts to enhance funding and treatment options to address opioid abuse and addiction issues. Overall Hospital Quality Star Ratings - Urged modifications to the methodology used to calculate Overall Hospital Quality Star Ratings Program. Prescription Drug Compounding - Supported ongoing efforts to maintain access to safe and effective drug compounding as the Drug Quality and Safety Act is implemented. Stark Law Reform - Monitored discussions in the House and Senate seeking reforms to the Stark Law. Voiced support for reforms that ease barriers to value-based care arrangements. Medical Device Cybersecurity - Urged additional steps to promote enhanced cybersecurity for networked medical devices.

Client expense: $175,000 · Firm income: Not reported

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

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

Client expense: $1,410,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Equal Employment Opportunity Commission (EEOC), 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), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI and the Administrations Blueprint on drug pricing RFI . Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Issues related to the Medicare Coverage Gap Discount. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 1703, Medical Product Communications Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974, Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.1703 Medical Product Communications Act H.R.2077 Restoring the Patient's Voice Act of 2017 S.2553/H.R.6144, Know the Lowest Price Act of 2018 S.2554/H.R.6143, Patient Right to Know Drug Prices Act H.R.3528/S.2460, The Every Prescription Carried Safely Act H.R.3447, Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 H.R.5343, Prescription Transparency Act of 2018 H.R.4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, accelerated generic approval, bio-similars.

Client expense: $766,889 · Firm income: Not reported

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

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) Monitored HR 277 American Health Care Reform Act of 2017 Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored S 1835 The Lower Premiums Through Reinsurance Act of 2017 Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored S 3158 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2019 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored S 2453 Ensuring the Value of the 340B Program Act of 2018 Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to pharmaceutical manufacturer and pharmacy contracting with respect to drug pricing. Issues included in the Proposed Part D Rule and accompanying RFI. Issues related to Medicaid Third Party Liability. Issues related to Medicaid Provider Enrollment. Issues related to prescription drug abuse. Regulatory design and coverage of pharmacy benefits in health reform exchanges and the commercial market (essential health benefits, e-prescribing, PBM disclosure requirements, specialty pharmacy, mail-service pharmacy, formulary transparency, and medical loss ratio). H.R.749/S.297, Lower Drug Costs through Competition Act HR.1038/S.413, Improving Transparency and Accuracy in Part D Spending Act H.R.1316, Prescription Drug Price Transparency Act S.637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 S.771, Improving Access to Affordable Prescription Drug Act H.R.1939/S.1044, Ensuring Seniors Access to Local Pharmacies Act H.R. 1703, Medical Product Communications Act H.R. 2026, Pharmaceutical Information Exchange Act H.R.2051, FAST Generics Act H.R.2212/S.974,Creating and Restoring Equal Access To Equivalent Samples Act of 2017 H.R.1703 Medical Product Communications Act H.R.2077 Restoring the Patient's Voice Act of 2017 H.R.3528, The Every Prescription Carried Safely Act H.R.3447, Furthering Access to Coordinated Treatment for Seniors (FACTS) Act of 2017 H.R.3922, Champioioning Healthy Kids Act Issues related to the affordability of prescription drugs and competitive marketplace, including: pedigree, FDA user fees, manufacturer market and data exclusivity, REMS, accelerated generic approval, biosimilars.

Client expense: $741,557 · Firm income: Not reported

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

S. 297: Increasing Competition in Pharmaceuticals Act S. 469: Affordable and Safe Prescription Drug Importation Act S. 771: Improving Access to Affordable Prescription Drugs Act H.R. 749: Lower Drug Costs Through Competition Act H.R. 1231: RACE for Children Act H.R. 1245: Affordable and Safe Prescription Drug Importation Act H.R. 1776: Improving Access to Affordable Prescription Drugs Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program H.R. 4710: 340B Preserving Patient Access for the Underserved and Safety-Net Entities Act or PAUSE Act - Provisions related to the 340B program 340B drug discount program policy issues H.R. 749: Lower Drug Costs Through Competition Act S. 469: Affordable and Safe Prescription Drug Importation Act H.Res. 403: Supporting the designation of March 2018 as Endometriosis Awareness Month S.Res.451: A resolution recognizing the significance of endometriosis as an unmet chronic disease for women and designating March 2018 as "Endometriosis Awareness Month"

Client expense: $2,890,000 · Firm income: Not reported

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

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R.4297 - Protecting Seniors Through Immunization Act HR4993, Vaccine Access Improvement Act, Technical fix to efficiently add new vaccines to VICPHR4297/S2103, Protecting Seniors through Immunization Act, HR 1625 - Consolidated Appropriatons Act of 2018 - Part D Doughnut HoleHR 1625 - Consolidated Approriations Act of 2018 - Ryan White and ADAP FundingHR 1892 - Further Extension of Continuing Appropriations Act, 2018 - Part D Doughnut Hole HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 4710 - 340B PAUSE ActS 2312 - HELP Act340B Drug Discount ProgramMedicare Part D - Doughnut Hole; Non-Interference ClauseFY19 Appropriations - DoD - Oral HealthFY19 Appropriations - HHS - Ryan White Program/ADAPHR 394 - Restoring Access to Medication ActS 85 - Restoring Access to Medication Act of 2017HR 4618 - To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication. Medicaid - access for chronic care patients Prescription Drug PricingS469 - Affordable and Safe Prescription Drug Importation Act HR 1245 - Affordable and Safe Prescription Drug Importation Act Drug Importation HR 242 - Medicare Prescription Drug Price Negotiation Act of 2017Draft legislation on opioids - FDA packaging and disposal Draft legislation on opioids - Tableting and Encapsulating Machine Regulation Act of 2018 H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial 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 Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $1,110,000 · Firm income: Not reported

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

Legislation and policies related to: Draft legislation to reauthorize and modernize the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act H.R. 749 - Lower Drug Costs through Competition Act H.R. 3692/S. 2317 - Addiction Treatment Access Improvement Act S. 297 - Increasing Competition in Pharmaceuticals Act S. 771/H.R. 1776 - Improving Access to Affordable Prescription Drugs Act S. 892 - Opioid Addiction Prevention Act of 2017 S. 2456 - CARA 2.0 Act of 2018

Client expense: Not reported · Firm income: $23,450

Government targets: Centers For Medicare and Medicaid Services (CMS), Education, Dept of, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Housing & Urban Development, Dept of (HUD), Medicare Payment Advisory Commission (MedPAC), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act of 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored HR 4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. General lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability.

Client expense: $1,830,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Natl Highway Traffic Safety Administration (NHTSA), SENATE, Transportation, Dept of (DOT)

H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial 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 Confirmation of Alex Azar Opioids shortages policy issues

Client expense: $9,960,000 · Firm income: Not reported

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

Group Purchasing - Conducted education and outreach efforts about the value hospital group purchasing organizations deliver the U.S. health care system. Drug Pricing - Supported the CREATES Act (S. 974), The Fair Access to Safe and Timely Generics Act (H.R. 2051), The Preserving Access to Affordable Generics (S.124), The Increasing Competition in Pharmaceuticals Act (S.297) and The Lower Drug Costs through Competition Act (H.R. 749). 340B Drug Discount program - Supported passage of H.R. 4392. Opposed H.R. 4710, S. 2312 and S.2453 and monitored ongoing congressional reports and discussions around the program. Children's Health Insurance Program - Supported passage of legislation to extend the Children's Health Insurance Program. Supported provision in H.R. 195 to extend the program for 6 years, and provisions in H.R. 1892 that continued funding for four additional years. Supported efforts to stabilize ACA insurance markets - including continuing funding for cost-sharing reduction subsidies and other efforts to stabilize insurance markets. Supported inclusion of provision to repeal the Independent Payment Advisory Board (IPAB) in H.R. 1892. Opioid Abuse - Monitored legislation to enhance funding and treatment options to address opioid abuse and addiction issues. Engaged in support of taking steps to ease shortages of hospital-administered intravenous opioid solutions.

Client expense: $185,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Implementation of Food and Drug Administration Safety and Innovation Act (FDASIA). Generic Drug User Fee Amendments (GDUFA). Biosimilar User Fee Act (BsUFA). Labeling of Generic Drugs. Drug Compounding. Biosimilars Naming. Pass Through Payments for Biosimilars. Prescription Drug Costs. Opioid abuse. H.R.2051: FAST Generics Act of 2017. S.124: Preserve Access to Affordable Generics Act. H.R.1245/S.469: Affordable and Safe Prescription Drug Importation Act. H.R.1892: Bipartisan Budget Act of 2018. Risk Evaluation and Mitigation Strategies (REMS). Biologic Exclusivity. Biologics Price Competition and Innovation Act (BPCIA). H.R.2562/S.1115: Making Pharmaceutical Markets More Competitive Act. S.771: Improving Access To Affordable Prescription Drugs Act. Pharmaceutical Exclusivity. H.R.2212/S.974: CREATES Act of 2017. H.R.2439/S.1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017. S.297: Increasing Competition in Pharmaceuticals Act. H.R.749: Lower Drug Costs through Competition Act. H.R.2430/S.934: FDA Reauthorization Act of 2017. H.R.1223/S.1509: Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017. Discussion Draft of H.R.__, FDA Accelerated Approval and Breakthrough Therapy Status. Discussion Draft of H.R.__, FDA and International Mail. Discussion Draft of H.R.__, Opioid Sparing. Discussion Draft of H.R.__, Packaging and Disposal. Discussion Draft of H.R.__, Long-term Efficiency. Discussion Draft of H.R.__, Misuse/Abuse.

Client expense: $970,000 · Firm income: Not reported

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

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

Client expense: $2,280,000 · Firm income: Not reported

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

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs through Competition Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S 191 Patient Freedom Act of 2017 Monitored S 761 Health Care Options Act of 2017 Monitored HR 1933 Health Care Options Act of 2017 Monitored HR 1628 American Health Care Act of 2017 Monitored Bipartisan Health Care Stabilization Act 2017 (proposed Alexander-Murray legislation) Monitored The Lower Premiums Through Reinsurance Act of 2017 (proposed Collins-Nelson legislation) Monitored S 2312 Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act Monitored politically appointed Senate-confirmed positions Monitored PL 115-141 Consolidated Appropriations Act, 2018 Monitored HR 4191 HHS Cybersecurity Modernization Act Monitored HR 4710 340B PAUSE Act Monitored H.R.4392 To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. J. Res. 16 a joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the independent payment Medicare advisory board H.J. Res 51/S. J. Res 17 Independent Payment Advisory Board Repeal H.R 1995 Value Based Insurance Design for Better Care Act H.R. 1004 Regulatory Integrity Act H.R. 1009/S. 676 OIRA Insight, Reform, and Accountability Act H.R. 1038/S. 413 Improving Transparency and Accuracy in Medicare Part D Spending H.R. 1101 Small Business Health Fairness Act H.R. 1121 Pre-Existing Conditions Protection Act H.R. 1148/S. 431 Furthering Access to Stroke Telemedicine (FAST) Act H.R. 1215 Protecting Access to Care Act H.R. 1267/S. 482 Personal Health Investment Today Act H.R. 1304 Self-Insurance Protection Act H.R. 1313 Preserving Employee Wellness Programs Act H.R. 1554 Jessie's Law H.R. 1565 Saving Lives, Saving Costs Act H.R. 1628 American Health Care Act H.R. 1703 Medical Product Communications Act H.R. 184 Protect Medical Innovation Act H.R. 1876 Good Samaritan Health Professionals Act H.R. 1953/S. 830 Treat and Reduce Obesity Act H.R. 2267/S. 1301 Resident Physician Shortage Reduction Act H.R. 246/S. 183 Jobs and Premium Protection Act H.R. 2550 Medicare Telehealth Parity Act H.R. 2556/S. 1016 CONNECT for Health Act H.R. 2797/S. 1334 Patient Choice and Quality Care Act H.R. 284 Advancing Medical Resident Training in Community Hospitals Act H.R. 2953/S. 2164 Preventive Health Savings Act H.R. 3044 to expand supplemental benefits to meet the needs of chronically ill Medicare Advantage enrollees H.R. 3059/S. 1441 Community Health Center and Primary Care Workforce Expansion Act H.R. 3120 to reduce the volume of future electronic health record-related significant hardship requests H.R. 3124/S. 1299 Preventing Diabetes in Medicare Act H.R. 3168 to provide continued access to Medicare Advantage plans for special needs H.R. 3224 Critical Access and Rural Equity Act H.R. 3245 Medicare Civil and Criminal Penalties Act H.R. 3263 to extend the Medicare independence at home medical demonstration program H.R. 3394 Teaching Health Centers Graduate Medical Education Extension Act H.R. 3447 Furthering Access to Coordinated Treatment for Seniors Act H.R. 3726 Stark Administrative Simplification Act of 2017 H.R. 3728 Empowering Medical Professionals and Optimizing Workforce Efficiency and Readiness Act H.R. 3820/S. 977 Medicare Home Health Flexibility Act H.R. 3862 National Health Service Corps Strengthening Act H.R. 3921 Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act H.R. 3922 Continuing Community Health and Medical Professional Programs to Improve Our Nation, Increase National Gains, and Help Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable Act H.R. 4541 Continuing Community Health and Medical Professional Programs to Improve Our Nation and Keep Insurance Delivery Stable H.R. 4613 Ensuring Patient Access to Healthcare Records Act H.R. 4616 to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 4617 to provide for a temporary moratorium on the medical device excise tax H.R. 4618 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication H.R. 4619 to provide temporary relief from the annual fee imposed on health insurance providers, to the extent that such fee is due to Puerto Rican health insurance H.R. 4620 Protecting Families and Small Businesses Act H.R. 4006 Community-Based Independence for Seniors Act of 2017 H.R. 4200/S. 2052 Healthcare Market Certainty and Mandate Relief Act H.R. 4520 to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2017 H.R. 4552/S. 1291 Advancing Medical Training in Community Hospitals Act H.R. 4105 to extend the health professions workforce demonstration project H.R. 4841 Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 592/S. 109 Pharmacy and Medically Underserved Areas Enhancement Act H.R. 706 Plan Verification and Fairness Act H.R. 741/S. 243 Rural Hospital Regulatory Relief Act H.R. 749 Lower Drug Costs Through Competition Act H.R. 766 Amend Title XVII of the Social Security Act to expand telehealth in Medicare H.R. 849/S. 260 Protecting Seniors' Access to Medicare Act H.R. 908 Medicare Advantage Quality Payment Relief Act H.R. 998 Searching for and Cutting Regulations that are Unnecessarily Burdensome (SCRUB) Act H.R. 2687/S. 1169 Medicaid Coverage for Addiction Recovery Expansion Act H.R.3727 To amend title XVIII of the Social Security Act to include additional telehealth services for purposes of MA organization bids, and for other purposes H.R. 4206/S. 2051 Medicare Care Coordination Improvement Act H.R. 5138 Bipartisan Health Savings Accounts Improvement Act Introduction of the Healthcare Cybersecurity Improvement Act Introduction of the Stark Law Modernization Act Pub L. 114-198 Comprehensive Addiction and Recovery Act Pub. L. 115-120 Fiscal Year 2018 Continuing Resolution Pub L. 115-80 National Clinical Care Commission Act Pub L. 115-123 Bipartisan Budget Act Pub L. 115-141 Fiscal Year 2018 Omnibus Appropriations Act Pub. L. 102-143 Telephone Consumer Protection Act Pub. L. 111-148 Patient Protection and Affordable Care Act (PPACA) Pub. L. 111-5 The American Recovery and Reinvestment Act Pub. L. 114-10 Medicare Access and CHIP Reauthorization Act (MACRA) Pub. L. 114-255 21st Century Cures Act Pub. L. 114-270 Expanding Capacity for Health Outcomes Act (ECHO) Pub. L. 114-329 American Innovation and Competitiveness Act Pub L. 115-63 Disaster Relief and Airway Extension Act Pub. L. 115-97 Tax Cuts and Jobs Act Reintroduction of TELE-MED Act of 2015 S. 108 Medical Device Access and Innovation Protection Act S. 297 Increasing Competition in Pharmaceuticals Act S. 1754 Training the Next Generation of Primary Care Doctors Act S. 1827 Keep Kids' Insurance Dependable and Secure Act S. 1829 Strong Families Act S. 1859 Healthcare Tax Relief Act S. 1899 to reauthorize and extend funding for community health centers and the National Health Service Corps S. 1967 Mandate Relief Act S. 251 Protecting Medicare from Executive Action Act S. 2278 State Offices of Rural Health Reauthorization Act S. 309 Community Based Independence for Seniors Act S. 464 Independence at Home Act H .R. 1933/S. 761 Health Care Options Act S. 787 Telehealth Innovation and Improvement Act S. 870 Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act S. 1978 Small Business and Family Health Tax Relief Act S. Con. Res. 3 Budget Resolution H.R. 3545 Overdose Prevention and Patient Safety Act H.R. 4613 Ensuring Patient Access to Healthcare Records Act S.1850 Jessie's Law H.R. 4206/S.2501 Medicare Care Coordination Improvement Act

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

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

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar HR 4710 - 340B PAUSE ActHR 4297 - Protecting Seniors Through Immunization Act of 2017H.J.Res. 123 - Making further continuing appropriations for fiscal year 2018, and for other purposes.Graham-Cassidy Health Care Bill (S. Amdt. 1030 to HR 1628, the American Health Care Act of 2017)HR 4297/S. 2103 - Protecting Seniors Through Immunization Act of 2017Monograph Reform House and Senate Continuing Resolution IPAB Legislation-House 340B Tax Reform

Client expense: $1,110,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE

S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) H.R. 749: Lower Drug Costs Through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Public Law No. 114-145) Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues Confirmation of Alex Azar TRICARE pharmacy pilot program

Client expense: $5,880,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), 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

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

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

Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of, White House Office

S. 64: Safe and Affordable Drugs from Canada Act of 2017 S. 92: Safe and Affordable Drugs from Canada Act of 2017 S. 297: Increasing Competition in Pharmaceuticals Act S. 469: Affordable and Safe Prescription Drug Importation Act S. 771: Improving Access to Affordable Prescription Drugs Act S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 H.R. 749: Lower Drug Costs Through Competition Act H.R. 1231: RACE for Children Act S. 456: RACE for Children Act H.R. 1245: Affordable and Safe Prescription Drug Importation Act H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 H.R. 1628: American Health Care Act of 2017 H.R. 1776: Improving Access to Affordable Prescription Drugs Act Prescription Drug User Fee Act (PDUFA) reauthorization Biologics User Fee Act (BsUFA) reauthorization 340B drug discount program policy issues Orphan Drug Act policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs PL 114-255: 21st Century Cures, implementation H.R. 749: Lower Drug Costs Through Competition Act H.R.2430/S.934: FDA Reauthorization Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1827: KIDS Act of 2017 H.R. 1703: Medical Product Communications Act of 2017 H.Res. 403: Supporting the designation of March 2018 as Endometriosis Awareness Month

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

HR 1156 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) S 1133 Patient Access to Higher Quality Health Care Act of 2017 (all sections of full text) HR 277 American Health Care Reform Act of 2017 (all sections of full text) Discussions involving Graham-Cassidy-Heller-Johnson (GCHJ) substitute legislation to HR 1628, to provide for reconciliation pursuant to Title II of the concurrent resolution on the budget for fiscal year 2017 Discussions pertaining to HR 1628 American Health Care Act of 2017 (all sections of full text) Discussions seeking guidance to minimize supply chain shortages for areas hit by natural disasters Educational discussions involving effectiveness of hospital trauma efforts HR 2 - Buschon Amendment (oppose) Monitored S 297 Increasing Competition in Pharmaceuticals Act Monitored HR 749 Lower Drug Costs trough Competition Act Monitored S 1115 Making Pharmaceutical Markets More Competitive Act Monitored HR 208 Ensuring Health Care Opportunities Act Monitored HR 2562 Making Pharmaceutical Markets More Competitive Act Monitored S191 Patient Freedom Act of 2017 Monitored S761 Health Care Options Act of 2017 Monitored HR1933 Health Care Options Act of 2017

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

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