Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 H.R. 2113 - The Prescription Drug STAR Act H.R. 1520, the Purple Book Continuity Act; H.R. 1503, the Orange Book Transparency Act; H.R. 1499, the Protecting Consumer Access to Generic Drugs Act; and H.R. 965, the CREATES Act; - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety, and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement, and pricing. - Issues related to healthcare legislation

Client expense: $2,950,000 · Firm income: Not reported

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

Issues relating to health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; the Breast Density & Mammography Reporting Act; H.R.820 & S.292, Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, the discussion draft of The Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Preservation of the Prevention and Public Health Fund and reauthorization of the CHIP program and FQHCs respecting H.R. 3922. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. Issues regarding access to care respecting the Bi-partisan Health Care Stabilization Act (Alexander-Murray) and S 1835, The Lower Premiums through Reinsurance Act.

Client expense: $650,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

Health issues impacting patients with rare diseases. H.R.5247/S.204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018. H.R.5115: Rare Disease Advancement, Research, and Education (RARE) Act of 2018. H.R.2587/S.1194: S.1194 - Medical Nutrition Equity Act of 2017. Congressionally Directed Medical Research Program. Short-term, limited-duration health plans. Association health plans.

Client expense: $60,000 · 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), Natl Institutes of Health (NIH), SENATE

Health issues impacting patients with rare diseases. Bipartisan Health Care Stabilization Act. H.R.5247/S.204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018. H.R.5115: Rare Disease Advancement, Research, and Education (RARE) Act of 2018. H.R.2587/S.1194: S.1194 - Medical Nutrition Equity Act of 2017. S.428: Advancing Care for Exceptional Kids Act of 2017 or the ACE Kids Act of 2017. Congressionally Directed Medical Research Program. S.Res.423: A resolution designating February 28, 2018, as "Rare Disease Day". Short-term, limited-duration health plans. Association health plans. H.R.2077: Restoring the Patient's Voice Act of 2017.

Client expense: $60,000 · 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), Natl Institutes of Health (NIH), SENATE

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 Correspondence with United States Senate in support of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S.204); Research relating thereto.

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

Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, President of the U.S., SENATE, Treasury, Dept of

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. 974 - Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2018 S. 2456 - CARA 2.0 Act of 2018 S. 2680 - Opioid Crisis Response Act of 2018 S. 3680 - Low Drug Prices Act S. 3754 - Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act S. 3775 - Affordable Drug Manufacturing 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)

H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act

Client expense: $79,366 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Bipartisan Healthcare Stabilization Act (Alexander-Murray) Affordable Care Act Implementation H.R. 2026 Pharmaceutical Information Exchange Act H.R. 878, H.R. 2368, S. 204 Right-to-Try Legislation S. 2554, Patient Right to Know Drug Prices Act

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

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

H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

Client expense: $580,000 · Firm income: Not reported

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

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act S. 2312 - The Helping Ensure Low-income Patients have Access to Care and Treatment Act S. 2453 - Ensuring the Value of the 340B Program Act of 2018 HR 4392 - Reversing the HOPPS rule reimbursement cut to 340B hospitals HR 5598 - 340B Optimization Act HR 2889 - Closing Loopholes for Orphan Drugs Act HR 6240 - Drug Discount Accountability Act (user fees) H.R.6071 - SERV Communities Act of 2018 S.204/H.R.878, Trickett-Wendler Right to Try Act of 2017 P.L.109-417, Pandemic and All-Hazards Preparedness Act (PAHPA) S.2852 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6294 - Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 S.974 - CREATES Act of 2017 - Issues related to the 340B Drug Discount Program - Issues relating to drug pricing - Development of policies to advance antimicrobial research, antiviral research, and novel product development environment, including advancing new market incentives. - Issues and policies relating to the Food and Drug Administration including biopharmaceutical development, drug safety and counterfeiting, and biosimilars. - General education about policies impacting pharmaceutical development, approval, reimbursement and pricing. - Issues related to healthcare legislation

Client expense: $1,480,000 · Firm income: Not reported

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

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization

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

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

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, clinical trials, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; H.R. 4122 & S. 2006, the Breast Density & Mammography Reporting Act; and H.R.820 & S.292, the Childhood Cancer STAR Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. The proposed Medical Records Fairness Act (no number yet). Issues regarding the Affordable Care Act premium tax credits and catastrophic plans, HR 6311. Issues regarding protections for people with pre-existing conditions, including S. 3388, HR 6898, and H. Res. 1066. Resolutions to disapprove the short-term rule, H.J. Res 140 and S. J. Res. 63. Advocacy against including the Association Health Plan provision of the House Farm bill in the conference report, H.R. 2 and s. 3042 (section 6004 of the House-passed version of the legislation). Issues involving patient navigation, including the Patient Navigation Assistance Act, HR 6808. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests, Verifying Accurate Leading-edge IVCT Development Act of 2018 or the VALID Act of 2018. H.R. 4897 & S. 2358 Women and Lung Cancer Research and Preventive Services Act of 2018. Issues related to caregiving, including H.R. 3759/S. 1028, the RAISE Family Caregivers Act, H. Res. 282, supporting initiatives to encourage parents and guardians to take measures to prevent sunburns in minors they care for.

Client expense: $1,610,710 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

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

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

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

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions

Client expense: $2,340,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office

Issues related to health care, the Food and Drug Administration (FDA), drug pricing and the 340b program. HR 878, Trickett Wendler Right to Try Act of 2017/S. 204, Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017 (P.L. 115-176); S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE

H.R. 246 - Jobs and Premium Protection Act. ACA Implementation, Medicare Advantage, Prescription Drugs. S. 1859 - Healthcare Tax Relief Act. S. 1978 - Small Business and Family Health Tax Relief Act of 2017. H.R. 4620 - Protecting Families and Small Businesses Act of 2017. Request for Information 0991-ZA49, HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. H.R. 6 - SUPPORT for Patients and Communities Act. S. 3120 - HEAL Act of 2018. S. 2554 - Patient Right to Know Drug Prices Act. H.R. 878; H.R. 2368/S. 204 - Right-to-Try Legislation.

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

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

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 ***, no specific bill, Raising Awareness of Cystic Fibrosis ***, no specific bill, appropriations for the Department of Health and Human Services, PDUFA, Sunshine, Orphan drugs, 340B, Innovation, EXPERT, Non-interference, drug development policies

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

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

H.R. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures

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

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

PL 114-255 - 21st Century Cures, implementation S. 204 - Right to Try Act of 2017 S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 2430 - FDA Reauthorization Act of 2017 no specific bills: Innovation, Duchenne Muscular Dystrophy, platform technologies, non-interference

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

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

PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB

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

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

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 456 - RACE for Children Act S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act no specific bills, 340B, Innovation, Transparency, Precision Medicine, NIH, Importation, Non-Interference, Vaccines, Biosimilars, Compounding

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

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

340B, PAHPA, antimicrobials, drug safety S. 204/H.R. 878 - Right to Try

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

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

PL 114-255 - 21st Century Cures, implementation S. 456 - RACE for Children Act S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act of 2017 H.R. 1480/S. 64/S. 92 - Safe and Affordable Drugs from Canada Act of 2017 H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act S. 2852 - Pandemic and All Hazards Preparedness Act ***, no specific bill(s), health care reform, Biosimilars, PDUFA and related FDA policies, Innovation, 340B, comparative effectiveness research, user fee reauthorization, non-interference, IPAB

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

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

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes H.R. 6 - SUPPORT for Patients and Communities Act S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018 H.R. 302 - FAA Re authorization Act of 2018 H. R. 6662 - Empowering Seniors Enrollment Decision Act of 2018 H.R. 6305 - Bipartisan HSA Improvement Act of 2018 H.R. 6312 - Personal Health Investment Today (PHIT) Act H.R. 6309 - To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 4616 - To amend the Patient Protection and Affordable Care Act 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. 6311 - To amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan

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

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

Antimicrobial resistance funding and research; heart disease; appropriations for NIH/FDA/AHRQ/CDC; Short term limited duration plans (STLDP) in Medicare; FDA guidance on Alzheimer's Disease Research; adult vaccinations in Medicare; opposition to the Balanced Budget Act; opposition to S.204/H.R.5247 Right to Try legislation

Client expense: Not reported · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

Support increased funding for federal antimicrobial resistance initiatives in the President's budget. Oppose HHS proposed rule regarding short-term limited duration plans (STLDs) Oppose Right to Try bill (H.R.5247 & S.204) Support Appropriations for FY2019 for FDA, NIH, NIA, AHRQ Submitted comments to FDA re draft guidance for early Alzheimer's Disease: Developing Treatments Submitted comments to CMS re Medicare Advantage improvements Submitted comments to CMS re Medicare Program Hospital Inpatient Prospective Payment proposed rule for FY2019 in support of adult immunizations Submitted letter to Congress re H.J.Res 2 in opposition to the Balanced Budget Act

Client expense: Not reported · Firm income: Not reported

Government targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE

H.R. 1628 American Health Care Act of 2017 H.R. 1776 and S. 771 Improving Access to Affordable Prescription Drugs Act S. 2406 H.R. 5002 Advancing Cutting-Edge (ACE) Research Act S. 2456, H.R. 5311Comprehensive Addition and Recovery Act CARA 2.0 of 2018 S.2680 Opioid Crisis Response Act of 2018 H.R. 5002 ACE Research Act H.R. 5247 S. 204 Right to Try Act of 2018

Client expense: $21,443 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Federal "Truth in Advertising" legislation; in general. H.R. 3928, the "Truth in Healthcare Marketing Act," all provisions. Issues pertaining to scope of practice; in general. Health care reform efforts; in general. Repeal of the Affordable Care Act, in general. Letter to the Food and Drug Administration regarding the forthcoming regulations relating to the over-the-counter sale of hearing aids. Letter to the Food and Drug Administration regarding National Shortages of Lidocaine with Epinephrine, Lidocaine, and Other Local Anesthetics. Coalition Letter to the Department of Health and Human Services Office of the Inspector General regarding information blocking by Electronic Health Record Vendors. Letter to Congress regarding H.R. 5247/S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, all provisions. H.Res.740, Expressing Support for the Designation of March 3, 2018, as World Hearing Day. H.R. 6, the SUPPORT for Patients and Communities Act; Section 303. S. 2852, the Pandemic All Hazards Preparedness and Advancing Innovation Act of 2018; provisions related to malpractice/tort reform and H.R. 1876. Issues pertaining to Language Equality and Acquisition for Deaf Kids (LEAD-K) and parent choice; in general. H.R. 1120, the "Alice Cogswell and Anne Sullivan Macy Act," all provisions. Coalition letter to the National Coordinator for Health Information Technology at HHS regarding HHS-ONC-2018-022 - Request for Information Regarding the 21st Century Cures Act Electronic Health Reporting Program.

Client expense: $230,000 · 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), Medicare Payment Advisory Commission (MedPAC), SENATE, U.S. Trade Representative (USTR), 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

CMS Manual - Reimbursement coding HR 5812 Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act of 2018 HR 2368 Right to Try Act HR 5247 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 S 204 Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 HR 878 Right to Try Act of 2017

Client expense: $150,000 · Firm income: Not reported

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)

H.R.1409 - Cancer Drug Parity Act of 2017 H.R.820/ S. 292 - Childhood Cancer STAR Act H.R.1231/S. 456 - RACE for Children Act H.R.1676/S. 693 - Palliative Care and Hospice Education and Training Act H.R.878 - Right to Try Act of 2017 S.204 - Trickett Wendler Right to Try Act of 2017 H.R.1854/ S. 778 - Prescription Drug Monitoring Act of 2017 Diagnostic Accuracy and Innovation Act (DAIA)(Draft legislation) H.R. 2430 FDA Reauthorization Act S. 934 FDA Reauthorization Act H.R. 2797/ S.1334Patient Choice and Quality Care Act (PCQCA) H.R. 2999Patient's Access to Treatment Act (PATA) H.R. 1628Better Care Reconciliation Act (BCRA) H.R. 1316Prescription Drug Pricing Transparency Act H.R. 2077 Restoring Patients Voices Act

Client expense: $223,857 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

340B, PAHPA, antimicrobials, drug safety S. 204/H.R. 878 - Right to Try

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

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

Issues relating to access to care, health disparities, childhood cancer, quality of life and palliative care, federal health care programs, genetic information, cancer, nutrition, tanning beds, skin cancer, and wellness, including: H.R.1676 & S.693, the Palliative Care and Hospice Education and Training Act; H.R. 4122 & S. 2006, the Breast Density & Mammography Reporting Act; H.R.820 & S.292, the Childhood Cancer STAR Act; and, H.R. 1231 & S. 456, the RACE for Children Act. In addition, issues related to reform of laboratory and diagnostic tests and the development of a new discussion draft for the Diagnostic Accuracy and Innovation Act; and H.R.772 and S.261, the Common Sense Nutrition Disclosure Act. Issues relating to anti-cancer medication cost-sharing parity respecting H.R. 1409. Issues regarding a national family caregiving strategy respecting S. 1719 and H.R. 1028. Issues regarding access to medicines respecting S.204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, as well as H.R.878, the Right to Try Act of 2017. Issues regarding lymphedema treatment respecting The Lymphedema Treatment Act, H.R. 930 and S. 497. The proposed Medical Records Fairness Act (no number yet). Issues regarding the Affordable Care Act premium tax credits and catastrophic plans, HR 6311. Issues regarding protections for people with pre-existing conditions, including S. 3388, HR 6898, and H. Res. 1066. Resolutions to disapprove the short-term rule, H.J. Res 140 and S. J. Res. 63. Advocacy against including the Association Health Plan provision of the House Farm bill in the conference report, H.R. 2 and s. 3042 (section 6004 of the House-passed version of the legislation). Issues involving patient navigation, including the Patient Navigation Assistance Act, HR 6808. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act, respecting Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, and protecting communities. Draft legislation on patient access to medical records. Draft legislation on FDA regulation of laboratory tests. H.R. 4897 & S. 2358 Women and Lung Cancer Research and Preventive Services Act of 2018. Issues related to caregiving, including H.R. 3759/S. 1028, the RAISE Family Caregivers Act.

Client expense: $1,230,000 · Firm income: Not reported

Government targets: Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Energy, Dept of, Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS), U.S. Agency for International Development (USAID), U.S. Trade Representative (USTR), Veterans Affairs, Dept of (VA), White House Office

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (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)

PL 114-255 - 21st Century Cures, implementation S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 S. 469 - Affordable and Safe Prescription Drug Importation act H.R. 749 - Lower Drug Costs Through Competition Act H.R. 878/S. 204 - Right to Try Act H.R. 2430 - FDA Reauthorization Act of 2017 S. 260/H.R. 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bil1s, innovation, non-interference, 340B, Hepatitis C, HPV, Shingles, anti-microbial resistance, transparency, Pandemic All Hazards Preparedness Act reauthorization

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

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

H.R. 1776/S. 771 - Improving Access to Affordable Prescription Drugs Act S. 637 - Creating Transparency to Have Drug Rebates Unlocked Act of 2017 H.R. 1245/S. 469 - Affordable and Safe Prescription Drug Importation Act Stopping the Pharmaceutical Industry From Keeping Drugs Expensive Act of 2017 H.R. 749 - Lower Drug Costs Through Competition Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 878/S. 204 - Right to Try Act S. 2852 - Pandemic and All Hazards Preparedness Act H.R. 6 - SUPPORT for Patients and Communities Act no specific bill, non-interference, 340b, FDASIA implementation, emergency preparedness, counter measures

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

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

H.R.6948 - Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018 Cell & Gene Therapy, including reimbursement Personalized Medicine Section 9008 of Patient Protection and Affordable Care Act FSA/HSA - Support reinstating coverage of OTC products 340B Drug Discount Program Dual Eligibles Program DQSA Implementation (Track & Trace) Certified Importer Program Drug Importation Reimbursement for medical devices GMP related to manufacturing sites Biosimilars Low-income Subsidy in Part D REMS Creates Act FCLCA Value of Medicines Drug Cost/Pricing Biosimilars Reimbursement Generic Drugs Medicaid FDA Regulations of Lab Developed Tests (LDT) Reimbursement for LDTs IPAB Generic Drug Labeling Outcomes-based Contracting PREA/BPCA Truthful, Non-Misleading Drug Information Part D Non-interference S.469 - Affordable and Safe Prescription Drug Importation Act Orphan Drugs Drug Pricing Transparency S.456 - RACE for Children Act S.204 - Trickett Wendler Right to Try Act of 2017 and related legislation Drug Compounding CMMI H.R.2641 - Promoting Life-Saving New Therapies for Neonates Act of 2017 Clinical Trials H.R.2430 - FDA Reauthorization Act of 2017 H.R.849 - Protecting Seniors' Access to Medicare Act of 2017 Virtual Clinical Trials S2465 - Sickle Cell Disease Part D Donut Hole PAUSE Act DQSA Implementation Omnibus bill CR PAHPA Reauthorizing Biosimilar Pass Through Payments Value Based Pricing

Client expense: $1,330,000 · Firm income: Not reported

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

Bipartisan Healthcare Stabilization Act (Alexander-Murray) Affordable Care Act Implementation H.R. 2026 Pharmaceutical Information Exchange Act H.R. 878, H.R. 2368, S. 204 Right-to-Try Legislation S. 2554, Patient Right to Know Drug Prices Act

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

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

- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions

Client expense: $1,980,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office

Issues related to health care, the Food and Drug Administration (FDA), drug pricing and the 340b program. HR 878, Trickett Wendler Right to Try Act of 2017/S. 204, Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017 (P.L. 115-176); S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE