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

Outreach and monitoring related to employer healthcare issues. Outreach and monitoring related to healthcare reform. Outreach and monitoring related to ERISA. Outreach and monitoring related to comprehensive tax reform. H.R. 878, Right to Try Act of 2017. H.R. 1301, Continuing Appropriations Amendments Act, 2018 (P.L. 115-124). H.R. 1625, Consolidated Omnibus Appropriations 2018 (P.L. 115-124). H.R. 1892, Bipartisan Budget Act of 2018 (P.L. 115-123). H.R. 3331, To amend title XI of the Social Security Act to promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology.

Client expense: Not reported · Firm income: Not reported

Government targets: 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

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. 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)

Support for the Right to Try Act, H. R. 878.

Client expense: Not reported · Firm income: Not reported

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

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 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

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

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

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

H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018

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

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

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)

Support for the Right to Try Act, H. R. 878.

Client expense: Not reported · Firm income: Not reported

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

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

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

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

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

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

PL 114-255 - 21st Century Cares, implementation medical device user fee reauthorization H.R. 2430, FDA Reauthorization Act of 2017 H.R. 2009, would clarify the FDA review process for medical imaging devices used with drugs known as contrast agents H.R. 2118, would require device manufacturers and third-parties who service those products to register with FDA and submit adverse event reports introduced S. 1069, which is identical to the manager's amendment language on the post-market pilot (Section 710) H.R. 878 - Right to Try H.R. 4191 - HHS Cybersecurity Modernization H.R. 6 - SUPPORT for Patients and Communities Act S. 3120 - HEAL Substance Use Disorders Act S. 2680 - Opioid Crisis Response Act ***, no specific bill(s), import safety, health care reform, 510K reform, medical device user fee program, companion diagnostics, clinical trials, registries, diagnostics regulation and payment reform, servicing equipment, VA acquisition

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

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

Cancer Drug Parity Act (HR 1409); the Right to Try Act (S 204, HR 878); the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 (HR 5247); Patients' Access to Treatments Act of 2017 (HR 2999); Childhood Cancer STAR Act (HR 820/S 292); RxCAP Act of 2017 (S 1347); the FAIR Care Act (S 2494); Patient Advocacy Transparency Act (S. 3000); insurance plan benefit design related to high-cost prescription drugs; Affordable Care Act market stabilization negotiations; pediatric cancer research

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

Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), 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

H.R. 878: Right to Try Act 2017; all provisions H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; all provisions H.R. 5385: Childrens Hospital GME Support Reauthorization Act of 2018; All provisions S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017; all provisions S. 2507: Improving Choices in Health Care Coverage Act; all provisions S. 2597: Childrens Hospital GME Support Reauthorization Act of 2018; All provisions No Bill Yet Introduced: Ideas to Make Health Care Affordable Again (Senator Cassidys White Paper); all provisions of draft No Bill Yet Introduced: American Patients First - The Trump Administration Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs; all provisions of draft Centers for Medicare & Medicaid Services Regulation# CMS-9924-P: Short-term, Limited-Duration Insurance; all provisions Employee Benefits Security Administration Regulation# RIN 1210-AB85: Definition of Employer Under Section 3 (5) of ERISA - Association Health Plans; all provisions Centers for Medicare & Medicaid Service - Section 1332: State Innovation Waivers; Provisions regarding Wisconsins Waiver Application Discussions related to Medicaid and Insurance Markets

Client expense: $220,000 · Firm income: Not reported

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

Support for the Right to Try Act, H. R. 878.

Client expense: Not reported · Firm income: Not reported

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