Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018

S. 92: Safe and Affordable Drugs from Canada Act S. 201 / H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 1876: Good Samaritan Health Professionals Act of 2017 H.R. 2077: the Restoring the Patient's Voice Act of 2017 H.R. 4116: Transparent Drug Pricing Act of 2017 S. 2387 / H.R. 4957: Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act S. 2406: Advancing Cutting Edge (ACE) Research Act S. 2478: End Taxpayer Subsidies for Drug Ads Act S. 2680: Opioid Crisis Response Act of 2018 S. 2891: Fighting the Opioid Epidemic with Sunshine Act H.R. 5634: Medical Cannabis Research Act Maintenance/expansion of Graduate Medical Education (GME); encouraging drug price transparency; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 92: Safe and Affordable Drugs from Canada Act S. 201 / H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 1827/ H.R. 3921 HEALTHY KIDS Act S. 2076 /H.R. 4256: Building Our Largest Dementia (BOLD) Infrastructure for Alzheimers Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act H.R. 1625 Vehicle for Consolidated Appropriations Act 2018 H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 1876: Good Samaritan Health Professionals Act of 2017 H.R. 1892: Continuing Resolution through March 23, 2018 H.R. 2077: the Restoring the Patient's Voice Act of 2017 H.R. 4116: Transparent Drug Pricing Act of 2017 H.R. 4841: Legislation to improve electronic prior authorization use in Medicare Advantage Maintenance/expansion of Graduate Medical Education (GME); encouraging drug price transparency; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

Client expense: $620,000 · 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. 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)

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

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs P.L. 115-241, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development S. 3660 / H.R. 5942, Health Equity and Accountability Act Issue: Support workforce grants to medical schools to improve health equity Issue: Oppose regulatory proposals to narrow the definition of sex Issue: Educate Congress and the administration, support training on substance use disorders, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid addiction Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. P.L. 115-176/H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. P.L. 115-271 SUPPORT for Patients and Communities Act H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education, and reauthorizing the Patient Centered Outcomes Research Institute. Provide grants to regional Centers of Excellence in substance use disorder education. Support policy eliminating Medicaid IMD exclusion and revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). H.R. 7328/ H.R. 6378/S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program S. 3366, Maternal CARE Act Issue: Support efforts to reduce preventable maternal mortality Issue: Support national preparedness infrastructure.

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

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

S. 297, Increasing Competition in Pharmaceuticals Act (Collins-McCaskill) - prescription drug costs S. 974, CREATES Act (Leahy-Grassley) - access to generic drugs and biosimilars S. 1115, Making Pharmaceutical Markets More Competitive Act (Collins-McCaskill) - accelerated approval of generic therapies S. 1131, FAIR Drug Pricing Act (Baldwin-McCain) - transparency in prescription drug pricing S. 2553, Know the Lowest Price Act (Stabenow) - pharmacist-patient communications S. 2554, Patient Right to Know Drug Prices Act (Collins) - pharmacist-patient communications, reporting of biosimilar pay-for-delay settlements S. 3194, Capping Prescription Costs Act (Warren) - capping prescription copays S. 3738, Hatch-Waxman Integrity Act (Hatch) - inter partes review process S. 3792, Preserve Access to Affordable Generics and Biosimilars Act (Klobuchar-Grassley) - pay-for-delay settlements H.R. 749, Lower Drug Costs Through Competition Act (Schrader-Bilirakis) - prescription drug costs H.R. 1703, Medical Product Communication Act (Griffith) - off-label exchange of information H.R. 2026, Pharmaceutical Information Exchange Act (Guthrie) - pre-approval health care economic information to payors H.R. 2051, Fair Access for Safe and Timely Generics Act (McKinley-Welch) - access to generic drugs H.R. 2212, CREATES Act (Marino-Cicilline) - access to generic drugs and biosimilars H.R. 2439, FAIR Drug Pricing Act (Schakowsky) - transparency in prescription drug pricing H.R. 2562, Making Pharmaceutical Markets More Competitive Act (Kelly) - accelerated approval of generic therapies H.R. 2999, Patients' Access to Treatments Act (McKinley) - limiting cost sharing in specialty drug tiers H.R. 5247, Right to Try Act (Fitzpatrick) - use of unapproved investigational drugs by patients with life-threatening conditions H.R. 6142, Reducing Drug Waste Act (Doggett) - packaging of medications H.R. 6157, Defense-Labor-HHS-Education Appropriations Act (Granger) -pharmaceutical price transparency in DTC advertising H.R. 6340, Capping Prescription Costs Act (Rosen) - capping prescription copays H.R. 6478, Biosimilars Competition Act (Sarbanes) - reporting of pay-for-delay settlements H.R. 6576, Drug-Price Transparency in Communications Act (Schakowsky) - disclosure of drug prices in DTC advertising H.R. 6733, Know the Cost Act (Carter) - pharmacist-patient communications H.R. 7251, Hatch-Waxman Integrity Act (Flores) - inter partes review process Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to prescription drug rebates; issues relating to prescription drug price blueprint; direct-to-consumer advertising for prescription drugs; issues relating to access for investigational drugs; and other issues relating to health care reform implementation.

Client expense: $1,540,000 · Firm income: Not reported

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

H. Con. Res. 128, FY19 House Budget Resolution H.J.Res. 143, Making further continuing appropriations for FY 2019, and for other purposes H. Res. 787, Providing for consideration of the bill (H.R. 4566) to amend the Dodd-Frank Wall Street Reform and Consumer Protection Act to provide relief to nonbanks from certain stress test requirements under such Act; providing for consideration of the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes; and for other purposes. H.R. 3, the Spending Cuts to Expired and Unnecessary Programs Act H.R. 695, Further Additional Continuing Appropriations Act, 2019 H.R. 2623, Lessening Regulatory Costs and Establishing a Federal Regulatory Budget H.R. 5961, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 S. 2976, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 H.R. 6147, Minibus II - FY 2019 Appropriations for Agriculture, Financial and General Government, Interior, and Transportation/HUD S. 3073, Interior and the Environment Appropriations H.R. 6258, House FY19 Financial Services and General Government Appropriations Act S. 3107, Senate FY19 Financial Services and General Government Appropriations Act H.R. 6776, FY 2019 Homeland Security Appropriations bill S. 3109, FY 2019 Homeland Security Appropriations bill H.R. 7264, Making further additional continuing appropriations for the FY 2019 and for other purposes S. 365, Make Taxpayers Fund CFPB S. 387, Consumer Financial Protection Bureau Accountability Act of 2017

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

Government targets: Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

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)

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)

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs P.L. 115-241, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Educate Congress and support training on substance use disorders, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid addiction Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. P.L. 115-176/H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education. Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 Issue: Provide grants to regional Centers of Excellence in substance use disorder education. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). H.R. 6378/S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program S. 3366, Maternal CARE Act Issue: Support efforts to reduce preventable maternal mortality H.R. 6, SUPPORT for Patients and Communities Act Issue: Support policy eliminating Medicaid IMD exclusion and revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations and investing in research and education, and reauthorizing the Patient Centered Outcomes Research Institute.

Client expense: $857,000 · Firm income: Not reported

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

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

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

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

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

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

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

H. Con. Res. 128, FY19 House Budget Resolution H. Res. 787, Providing for consideration of the bill (H.R. 4566) to amend the Dodd-Frank Wall Street Reform and Consumer Protection Act to provide relief to nonbanks from certain stress test requirements under such Act; providing for consideration of the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes; and for other purposes. H.R. 3, the Spending Cuts to Expired and Unnecessary Programs Act H.R. 2623, Lessening Regulatory Costs and Establishing a Federal Regulatory Budget H.R. 5895, Minibus I - FY19 Appropriations for Energy and Water, Military Construction - Veterans Affairs, and Legislative Branch S. 2975, Minibus I - FY19 Appropriations for Energy and Water, Military Construction - Veterans Affairs, and Legislative Branch H.R. 5961, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 S. 2976, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 H.R. 6147, Minibus II - FY 2019 Appropriations for Agriculture, Financial and General Government, Interior, and Transportation/HUD S. 3073, Interior and the Environment Appropriations H.R. 6157, Minibus III - a Consolidated Appropriations Measure for FY 2019 DOD, Labor/HHS/Education, and a CR H.R. 6258, House FY19 Financial Services and General Government Appropriations Act S. 3107, Senate FY19 Financial Services and General Government Appropriations Act H.R. 6470, Labor/HHS Appropriations bill S. 3158, FY19 Labor/HHS Appropriations bill H.R. 6776, FY 2019 Homeland Security Appropriations bill S. 3109, FY 2019 Homeland Security Appropriations bill S. 365, Make Taxpayers Fund CFPB S. 387, Consumer Financial Protection Bureau Accountability Act of 2017

Client expense: $240,000 · Firm income: Not reported

Government targets: Commodity Futures Trading Commission (CFTC), Consumer Financial Protection Bureau (CFPB), Federal Communications Commission (FCC), Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Management & Budget (OMB), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

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

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. 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: $63,807 · 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.

Client expense: $200,000 · 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

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

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: $210,000 · Firm income: Not reported

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

H.R. 5247: TRICKETT WENDLER, FRANK MONGIELLO, JORDAN MCLINN, AND MATTHEW BELLINA RIGHT TO TRY ACT OF 2018; ALL PROVISIONS OF THE BILL H.R. 5115: RARE dISEASE ADVANCEMENT, RESEARCH, AND EDUCATION (RARE) ACT OF 2018; ALL PROVISIONS OF THE BILL S. 204: TRICKETT WENDLER, FRANK MONGIELLO, JORDAN MCLINN, AND MATTHEW BELLINA RIGHT TO TRY ACT OF 2017; ALL PROVISIONS OF THE BILL GENERAL DISCUSSIONS REGARDING PRESERVATION OF ORPHAN DRUG ACT GENERAL DISCUSSIONS REGARDING FOOD AND DRUG ADMINISTRATION DISEASE EDUCATION GENERAL DISCUSSIONS REGARDING GENE THERAPY, RARE BRAIN DISORDER, FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE MEETINGS AND PRESCRIPTION DRUG COST

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Right to Try H.R. 5247 Issues related to Health Care

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

Government targets: Commerce, Dept of (DOC), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Labor Relations Board (NLRB), President of the U.S., SENATE, U.S. Trade Representative (USTR)

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)

Issue: Educate congressional staff on academic medicines missions, including education, research, patient care, GME, workforce, and physician shortages in rural and urban communities. Issue: Support continuation of high-quality affordable health insurance through preservation of current levels of health care coverage. Support programs and funds for safety-net providers. H.R. 3728, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) Act of 2017 Issue: Support reauthorization of Title VII health professions programs H.R.5385, Childrens Hospital GME Support Reauthorization Act Issue: Support reauthorization of the Childrens Hospital GME program H.R. 959/S. 1109 Title VIII Nursing Workforce Reauthorization Act of 2017 Issue: Support reauthorization of Title VIII nursing workforce development programs S.3095 / H.R. 2574, Building a Health Care Workforce for the Future Act Issue: Support bill to increase scholarship opportunities for medical students and encourage primary care workforce development Issue: Educate Congress and support training on substance abuse, pain management, and safe prescribing practices. Strategies to prevent, identify, and treat opioid dependence Issue: Support reauthorization of the Patient Centered Outcomes Research Institute (PCORI) and the Patient Centered Outcomes Research Trust Fund P.L. 114-255, 21st Century Cures Act Issue: Support Implementation of 21st Century Cures Act Issue: Promote resilience of health professionals Issue: Support policies to address IV fluid shortages exacerbated by hurricanes, and educate Congress on the shortage of IV saline fluid and injectable drug shortage. H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act. Issue: Oppose Right to Try legislation that removes safety measures under FDAs current expanded access program. S.2680, Opioid Crisis Response Act of 2018 S.2711, Enhancing Access to Addiction Treatment Act of 2018 Issue: Support policies to address the opioid epidemic including improving coverage and payment for non-opioid therapies, enhancing usability of PDMPs, addressing physician shortages, promoting medication assisted treatment, eliminating Medicare limits on in-patient psychiatric hospital treatment, eliminating Medicaid IMD exclusion, aligning privacy regulations, and investing in research and education. H.R. 6082, the Overdose Prevention and Patient Safety Act Issue: Support legislation revising 42 Code of Federal Regulations (CFR) Part 2 to amend the Public Health Service Act to align federal privacy standards for substance use disorder (SUD) patient records more closely with standards under the Health Insurance Portability and Accountability Act (HIPAA). S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPAI) Pandemic and All-Hazards Preparedness Reauthorization Act of 2018 (Draft House legislation) Issue: Support the Hospital Preparedness Program and the reauthorization of the Pandemic and All-Hazards Preparedness Act. Support increased funding authorization levels. H.R.4776 Hospital Preparedness Reauthorization Act of 2018. Issue: Support reauthorization of the Hospital Preparedness Program Issue: Oppose restrictions on fetal tissue and embryonic stem cell research. Issue: Amend Controlled Substances Act to improve MAT waiver process for qualified health professionals. H.R. 5261, Treatment, Education, and Community Help to Combat Addiction Act of 2018 Issue: Provide grants to regional Centers of Excellence in substance use disorder education. Issue: Support legislative solutions to fire arm related injuries and fatalities including research, public health surveillance, and firearm background checks. H.R. 4392, To provide that the provision of the Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs final regulation relating to changes in the payment amount for certain drugs and biologicals purchased under the 340B drug discount program shall have no force or effect, and for other purposes. Issue: Support rescission of Medicare cuts to hospitals that participate in 340B Drug Pricing Program H.R. 4710, 340B PAUSE Act Issue: Oppose bill that would impose a moratorium on 340B hospitals and other issues S. 2312, 340B HELP Act Issue: Oppose bill that would impose a moratorium and add additional reporting requirements for 340B hospitals S.2453, Ensuring the Value of the 340B Program Act of 2018 Issue: Oppose bill that would require hospitals to report total 340B acquisition costs H.R. 6071, Stretching Entity Resources for Vulnerable Communities Act Issue: Support bill to rescind Medicare cuts to 340B hospitals and improve program integrity H.R. 5598: 340B Optimization Act Issue: Oppose bill that would change eligibility metrics in the 340B program H.R. 6240, Drug Discount Accountability Act Issue: Oppose bill that would impose a user fee on hospitals that participate in the 340B program

Client expense: $1,339,000 · Firm income: Not reported

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

Monitored issues related to H.R. 2368 and H.R. 878, The Right to Try Act of 2017 and S. 204 and H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn & Matthew Bellina Right to Try Act of 2017. Issues related to opioids and prescription drug monitoring programs including H.R. 5812, the CONNECTIONS Act.

Client expense: Not reported · Firm income: $63,750

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

Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); The Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act (i.e., the "SCREEN Act")(H.R. 5228); Opioid Crisis Response Act of 2018 (S. 2680); Expanding Access to Low Cost Generic Drugs Act (S. 2476); Preserve Access to Affordable Generics Act (S. 124); Regulatory exclusivity; Improving Access To Affordable Prescription Drugs Act (S. 771/H.R. 1776); Legislation on drug labeling; Comprehensive Addiction Resources Emergency Act (CARE Act)(S. 2700/HR 5545); SOUND Disposal and Packaging Act (HR 5687); Biologics patent settlements; Long-Term Opioid Efficacy Act of 2018 (HR 5811); SAFETY Act of 2018 (H.R. 5803); Insulin pricing; H.R. 5752, the Stop Illicit Drug Importation Act of 2018; proposed legislation regarding tableting and encapsulating opioid products; Drug Importation; Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act (HR 5247/S. 204; CREATES Act (HR 2212/S. 974)

Client expense: Not reported · Firm income: $290,000

Government targets: HOUSE OF REPRESENTATIVES, 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: $180,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), 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. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 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. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH 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 - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding 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. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to 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 Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues 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 Opioids shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $5,540,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)

H.R. 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. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5353; Leonard Lance, Eliminating Opioid Infectious Diseases 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 - To require improved packaging and disposal methods with respect to certain drugs H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 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 pri S. 2312: HELP Act - Provisions related to 340B progr S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B prog S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding 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 Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issue Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $790,000 · Firm income: Not reported

Government targets: Council of Economic Advisers (CEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Vice President of the U.S.

S. 92: Safe and Affordable Drugs from Canada Act S. 201 / H.R. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S. 469: Affordable and Safe Prescription Drug Importation Act S. 1131/ H.R. 2439: FAIR Drug Pricing Act S. 2260 / H.R. 4733: Opioids and STOP Pain Initiative Act H.R. 1776: Improving Access to Affordable Prescription Drugs Act H.R. 1876: Good Samaritan Health Professionals Act of 2017 H.R. 2077: the Restoring the Patient's Voice Act of 2017 H.R. 4116: Transparent Drug Pricing Act of 2017 S. 2387 / H.R. 4957: Concentrating on High-Value Alzheimers Needs to Get to an End (CHANGE) Act S. 2406: Advancing Cutting Edge (ACE) Research Act S. 2478: End Taxpayer Subsidies for Drug Ads Act S. 2680: Opioid Crisis Response Act of 2018 S. 2891: Fighting the Opioid Epidemic with Sunshine Act H.R. 5634: Medical Cannabis Research Act Maintenance/expansion of Graduate Medical Education (GME); encouraging drug price transparency; NIH funding including the BRAIN Initiative; Congressionally-Directed Medical Research Program funding; concussion related issues.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 5247 - Federal Right to Try Bill

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

S. 2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R. 4710, 340B PAUSE Act; Discussions to clarify or reform the 340B program; Discussions on value-based drug contracting; S. 204, H.R. 878, Trickett Wendler Right to Try Act of 2017; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; H.R. 2077, Restoring the Patient's Voice Act of 2017; H.R. 1409, Cancer Drug Parity Act; S. 637, Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017; S. 1681, A bill to require persons who undertake Federally funded research and development of drugs to enter into reasonable pricing agreements with the Secretary of Health and Human Services; Proposals related to drug pricing; S. 1347, RxCAP Act of 2017; 42 USC 1320a-7b, Anti-Kickback Statute; H.R. 5867, H.R. 6142, Reducing Drug Waste Act of 2018; Discussions related to mental health/depression in the opioid epidemic;

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

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

House, FY 2019 Homeland Security Appropriations Bill S. 3109, FY 2019 Homeland Security Appropriations Bill FY19 Labor/HHS Appropriations House bill S. 3158, FY19 Labor/HHS Appropriations bill H. Con. Res. 128, FY19 House Budget Resolution H. Res. 787, Providing for consideration of the bill (H.R. 4566) to amend the Dodd-Frank Wall Street Reform and Consumer Protection Act to provide relief to nonbanks from certain stress test requirements under such Act; providing for consideration of the bill (H.R. 5247) to authorize the use of eligible investigational drugs by eligible patients who have been diagnosed with a stage of a disease or condition in which there is reasonable likelihood that death will occur within a matter of months, or with another eligible illness, and for other purposes; and for other purposes. H.R. 3, the Spending Cuts to Expired and Unnecessary Programs Act H.R. 2623, Lessening Regulatory Costs and Establishing a Federal Regulatory Budget H.R. 5895, FY19 Energy and Water Appropriations S. 2975, FY19 Energy and Water Appropriations H.R. 5961, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 S. 2976, Agriculture, Rural Development, & FDA Appropriations Act for FY 2019 H.R. 6147, Interior and the Environment Appropriations S. 3073, Interior and the Environment Appropriations H.R. 6258, House FY19 Financial Services and General Government Appropriations Act S. 3107, Senate FY19 Financial Services and General Government Appropriations Act S. 365, Make Taxpayers Fund CFPB S. 387, Make Taxpayers Fund CFPB

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

Government targets: Commodity Futures Trading Commission (CFTC), Federal Communications Commission (FCC), Federal Reserve System, Federal Retirement Thrift Investment Board, Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Merit Systems Protection Board, Natl Park Service (NPS), Office of Personnel Management (OPM), Office of Special Counsel, Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), SENATE, Securities & Exchange Commission (SEC), Treasury, Dept of, U.S. Customs & Border Protection

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.

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

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

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

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

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

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

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: $13,899 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Real World Evidence Patient Reported Outcomes Medical Product Communications Act of 2017, HR 1703 Prescription Drug Price Transparency Act, HR 1316 Trickett Wendier, Frank Morigeiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018, HR 5247, S 204

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

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

H.R. 1409 Cancer Drug Parity Act; H.R. 5247, Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018; S. 2554/HR. 6143 Patient Right to Know Drug Prices Act; Opioid Monitoring; Drug pricing Monitoring, HR. 592/ S. 109 Pharmacy and Medically Underserved Areas Enhancement Act.

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE