Helping Ensure Low-income Patients have Access to Care and Treatment

H.R.3 - Lower Drug Costs Now Act of 2019 Prescription Drug Pricing Reduction Act (PDPRA) of 2019 S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B 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 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget 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 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 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 H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. -Issues related to Medicare and Medicaid coverage and reimbursement -Issues related to the 340B Drug Discount Program -Issues related to drug pricing -Medicare reimbursement for biosimilars -MACRA treatment and reimbursement of Part B drugs -Medicare payments for inpatient antimicrobials -Issues related to drug importation

Client expense: $2,610,000 · 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

S.977 - Transparent Drug Pricing Act of 2019 H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B 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 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget 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 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 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 H.R. 965, the CREATES Act H.R.269/S.1379, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 (P.L.116-22). S.1895, Lower Health Care Costs Act of 2019. - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

Client expense: $1,610,000 · 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

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.

Client expense: $1,610,000 · 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

Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act (Doggett compulsory licensing bill) Issues related to Part D coverage gap, no specific bill Transitional drug add-on payment (TDAPA), dialysis bundled payment system issues, no specific bill

Client expense: $3,250,000 · Firm income: Not reported

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

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B 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 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget 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 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act S.551, REFUND Act of 2019 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 H.R. 965, the CREATES Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to the International Pricing Index for Medicare Part D

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

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

Outreach and monitoring related to health, Medicaid and Medicare issues. H.R. 4710, 340B PAUSE Act. 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. H.R. 541, Improving Oversight and Accountability in Medicaid Non-DSH Supplemental Payments Act. H.R. 1892, Bipartisan Budget Act of 2018 (P.L. 115-123). H.R. 195, Extension of Continuing Appropriations Act, 2018 (P.L. 115-120). S. 2183, CHIP Stability Act. S. 2312, HELP Act.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Outreach and monitoring related to health, Medicaid and Medicare issues. H.R. 4710, 340B PAUSE Act. 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. H.R. 541, Improving Oversight and Accountability in Medicaid Non-DSH Supplemental Payments Act. H.R. 1892, Bipartisan Budget Act of 2018 (P.L. 115-123). H.R. 195, Extension of Continuing Appropriations Act, 2018 (P.L. 115-120). S. 2183, CHIP Stability Act. S. 2312, HELP Act.

Client expense: Not reported · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Legislative monitoring and outreach on issues related to TORT Reform Health IT. Monitor Administrative action regarding Presidents Infrastructure Plan. H.R. 2843, Medicaid and CHIP Quality Improvement Act of 2017. S. 1317, Medicaid and CHIP Quality Improvement Act of 2017. H.R. 4710, 340B PAUSE Act. S. 2312, HELP Act. H.R. 1625, Consolidated Omnibus Appropriations 2018 (P.L. 115-124).

Client expense: Not reported · Firm income: Not reported

Government targets: SENATE

Legislative monitoring and outreach on issues related to Medicaid and Medicare. Monitor Administrative action regarding Presidents Infrastructure Plan. H.R. 2843, Medicaid and CHIP Quality Improvement Act of 2017. S. 1317, Medicaid and CHIP Quality Improvement Act of 2017. H.R. 4710, 340B PAUSE Act. S. 2312, HELP Act. H.R. 1625, Consolidated Omnibus Appropriations 2018 (P.L. 115-124).

Client expense: Not reported · Firm income: Not reported

Government targets: SENATE

ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed the proposed public charge rule and adding Medi-Cal to the list of programs that would be considered in making a public charge determination.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed proposed public charge rule, which would punish children with disabilities and complex medical conditions, and make it harder for them to pursue lawful citizenship.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

Stopping the application of the sequester cut (current and new) to Medicare Part B drug reimbursement (no bill). Fixing the 340B drug discount program, including PAUSE Act (H.R. 4710), HELP Act (S. 2312, and Ensuring the Value of the 340B Program Act (S. 2453) and other legislation in progress. Fixing Medicare Part B drug reimbursement by eliminating the manufacturer-to-wholesaler prompt pay discount from the calculation of average sales price, the basis of Part B drug reimbursement (H.R. 1920, S. 1304). Moving Medicare Part B to Part D (no bill). Misc. issues dealing with pharmacy benefit managers and patient and pharmacy abuses (includes bills H.R 1316 - Prescription Drug Price Transparency Act; H.R.1038 - Improving Transparency and Accuracy in Medicare Part D Spending Act; and H.R. 5958 - Phair Pricing Act of 2018}. Oncology Care Model (CMS/CMMI; no bill). Various drug pricing/costs (no bill). STEP therapy (no bill). International Pricing Index Model (no bill)

Client expense: $138,700 · Firm income: Not reported

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

Medicare Part B coverage and reimbursement issues Coding and reimbursement for oncology drugs/biologics/biosimilars S 2312 "Helping Ensure Low-Income Patients have Access to Care and Treatment" (HELP Act) S 2453 "Ensuring the Value of the 340B Program Act of 2018" Senate Report 115-289 to accompany S.3158 Appropriations bill for the Department of Labor, Health and Human Services, and Education, and related agencies for the fiscal year 2019 H.R. 6142 Reducing Drug Waste Act H.R. 4710 Protecting Access for the Underserved and Safety-Net Entities H.R 6157 -- Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 HR 6505 - Medicare Negotiation and Competitive Licensing Act Issues related to Part D coverage gap, no specific bill

Client expense: $2,700,000 · Firm income: Not reported

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

H.R. 4710 340B PAUSE Act S. 2312 HELP Act S. 2957; H.R. 5385 Children's Hospital Support Graduate Medical Education Reauthorization H.R. 5678 Rural Emergency Medical Center Act Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Payment Systems and Quality Reporting Programs, CMS-1695-P Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction OPTN's Public Comment Proposal Liver and Intestine Distribution Using Distance from Donor Hospital

Client expense: Not reported · Firm income: $7,900

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

H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 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. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal 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. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act 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. 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 -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program 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 S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $920,000 · 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), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)

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. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues 340B drug discount program policy issues

Client expense: $1,820,000 · 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.

Repeal of the Affordable Care Act H.R. 1628 The American Health Care Act Development of legislation to protect essential hospitals Issues related to telehealth Mental Health Essential Health Benefits created by the Affordable Care Act Access to hospital emergency services Issues related to the 340B Drug Pricing Program HR1628 Better Care Reconciliation Act ACA Cost Sharing Reduction Subsidies Graham-Cassidy Amendment to HR 1628 340B drug pricing program HR3545-Overdose, Prevention and Patient Advocacy Act HR4392 CMS OPPS 340b rule moratorium HR4710 340b PAUSE Act Bipartisan Healthcare Stabilization Act of 2017 Opioid Crisis Response Act of 2018 42 CFR Part 2 IMD Exclusion Prescription drug monitoring programs H.R. 5197, S. 2516, Alternatives to opioids in the emergency dept Act H.R. 5102, Substance Use Disorder Workforce Loan Repayment Act H.R. 5261, Treatment, Education, and Community Help to Combat Opioid Addiction Act Poison Center Network Enhancement Act A Bill to support the peer support specialist workforce HR6 Support for Patients and Communities Act H.R. 4710 PAUSE Act HELP Act S. 2312 HR6378 Pandemic and All Hazards Preparedness and Advancing Innovation Act S.974 CREATES Act S.2843 Opioid Workforce Act HEAL Act S.3120 SERV Communities Act H. R. 6071 S.428, H.R. 3325 The Advancing Care for Exceptional (ACE) Kids Act Cassidy Surprise Billing Draft H.R.6 Support for Patients and Communities Act Protecting Patients from Surprise Medical Bills Hassan Surprise Billing-S. 3592, No more Surprise Medical Bills Act H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office

P.L. 111-148 - Patient Protection and Affordable Care Act Health Information Technology Health workforce shortage issues, Title VII and Title VIII of the Public Health Service Act, nursing, graduate nursing education, nursing-managed health clinics Health wellness and prevention programs University Center for Excellence in Developmental Disabilities Leadership in Education in Neurodevelopmental Disabilities and Related Disorders (LEND) S. 850, H.R. 1922, Foreign Medical Schools Accountability Act H.R. 959, Title VIII Nursing Workforce Reauthorization Act H.R. 3728 Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness Act of 2017 (EMPOWER) Act S.2873, P.L. 114-270, ECHO Act S. 2184, Veterans Community Care and Access Act H.R. 3922, CHAMPIONING Healthy Kids Act S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act H.R. 6781, Mental Health Telemedicine Expansion Act H.R.6, SUPPORT for Patients and Communities Act

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4710 - 340B Protecting Access for the Underserved and Safety-Net Entities Act (340B 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 Part D Medicare Program (including Coverage Gap and other offsets in H.R.1892/P.L.115-123, Bipartisan Budget 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 6071 - SERV Communities Act HR 6240 - Drug Discount Accountability Act (user fees) S.3787 - DISARM Act of 2018 H.R. 7077, the Restoring the Patients Voice Act - Issues related to Medicare and Medicaid coverage and reimbursement - Issues related to the 340B Drug Discount Program - Issues related to drug pricing - Medicare reimbursement for biosimilars - MACRA treatment and reimbursement of Part B drugs - Medicare payments for inpatient antimicrobials - Issues related to Right to Try - Issues related to drug importation - Issues related to Part D Medicare Program including coverage gap and other offsets

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

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

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. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 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. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal 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. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing 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. 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. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids 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 S. 3775: Affordable Drug Manufacturing Act of 2018 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 Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)

Client expense: $6,030,000 · Firm income: Not reported

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

Issued relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); and the Ensuring the Value of the 340B Program Act (S. 2453). Biodefense research, development and procurement issues; Pandemic All Hazards Preparedness Act (PAHPA) reauthorization; pandemic flu; MCM priority review voucher program Issues related to biosimilars, generally; Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (S. 974/H.R. 2212) Issues related to drug pricing and value, generally, including the HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. Issues related to the importation of prescription medicines, including the Affordable and Safe Prescription Drug Importation Act (H.R. 1245/S. 469); and the Improving Access to Affordable Prescription Drugs Act (H.R. 1776/S. 771)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to Medicare Part B Issues related to Medicare Part D Coding and reimbursement for oncology drugs/biologics/biosimilars Issues relating to the 340B Drug Pricing Program, including the 340B Protecting Access for the Underserved and Safety-Net Entities (PAUSE) Act (H.R. 4710); the Helping Ensure Low-income Patients have Access to Care and Treatment (HELP) Act (S. 2312); the Ensuring the Value of the 340B Program Act (S. 2453), and the 340B Optimization Act (H.R. 5598)

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

H.R. 4710 340B PAUSE Act S. 2312 HELP Act S. 2957; H.R. 5385 Children's Hospital Support Graduate Medical Education Reauthorization H.R. 5678 Rural Emergency Medical Center Act Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Payment Systems and Quality Reporting Programs, CMS-1695-P Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction OPTN's Public Comment Proposal Liver and Intestine Distribution Using Distance from Donor Hospital

Client expense: Not reported · Firm income: $37,000

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

H.R. 4710 340B PAUSE Act S. 2312 HELP Act S. 2957; H.R. 5385 Children's Hospital Support Graduate Medical Education Reauthorization H.R. 5678 Rural Emergency Medical Center Act Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Payment Systems and Quality Reporting Programs, CMS-1695-P Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction OPTNs Public Comment Proposal Liver and Intestine Distribution Using Distance from Donor Hospital

Client expense: $141,000 · Firm income: Not reported

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

H.R. 4710 - 340B PAUSE Act; provisions relating to 340B drug pricing S. 2453 - Ensuring the Value of the 340B Program Act of 2018; provisions relating to 340B drug pricing S. 2312 - HELP Act; provisions relating to 340B drug pricing H.R. 6071 - SERV Communities Act; provisions relating to 340B drug pricing 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; provisions related to 340B drug pricing. Centers for Medicare and Medicaid Services' FY2019 Inpatient Prospective Payment System (IPPS) Final Rule comments/CAR-T therapy reimbursement Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule/Physician Fee Schedule proposed rule comments Medicare and Medicaid Programs; Regulatory Provisions to Promote Program Efficiency, Transparency and Burden Reduction, CMS-3346-P, proposed rule comments Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations - Pathways to Success, CMS-1701-P, proposed rule comments

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

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

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

Issues related to the implementation of PL 111-148 "Patient Protection and Affordable Care Act," all provisions pertaining to the Center for Medicare and Medicaid Innovation (CMMI) and federal programs. Issues related to the implementation of PL 97-414 "Orphan Drug Act," all provisions. HR 4710 "340B Protecting Access for the Underserved and Safety-net Entities Act," all provisions. S 2312 "Helping Ensure Low-income Patients have Access to Care and Treatment" (HELP Act), all provisions. S 2453 "Ensuring the Value of the 340B Program Act of 2018," all provisions. HR 5598 "340B Optimization Act," all provisions. HR 6071 "SERV Communities Act," all provisions. HR 6240 "Drug Discount Accountability Act," all provisions.

Client expense: $1,400,000 · Firm income: Not reported

Government targets: HOUSE OF REPRESENTATIVES, SENATE

The 340B Drug Pricing Program; FY19 LHHS Appropriations; final 2018 and proposed 2019 Outpatient Prospective Payment System Rule; proposed and final rules regarding 340B ceiling price calculations and manufacturer civil monetary penalties; delay of 340B ceiling price database; S.2312, S.2453, H.R.4710, H.R.4392, H.R.5598, H.R.6071, H.R.6240, H.R.6273, and other legislation relevant to the 340B drug pricing program

Client expense: $231,609 · Firm income: Not reported

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

340B Drug Pricing Program - Opposed Medicare reimbursement reductions for hospitals eligible for the 340B drug pricing program. Supported passage of H.R. 4392, H.R 6071. Opposed H.R. 4710, H.R. 6240, S. 2312 and S.2453. Outpatient Prospective Payment System Site-Neutral Payment Reductions - Opposed implementation of Medicare payment changes that would reduce reimbursement for hospital outpatient facilities.

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

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

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

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

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

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

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

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

Monitor legislation affecting Medicare 340B payments. H.R. 4392 which would impose a permanent moratorium on the new medicare policy that would reduce payments to 340B eligible entities by 27% and HR 4710 which would freeze the 340B program to new entrants well as create onerous new reporting systems for all hospitals, HR 4710, 340B PAUSE Act. would stop new disproportionate share hospitals from enrolling in the Medicare 340B program , stop registration for new child sites and establish new reporting requirements for dSH, cancer and childrens hospitals ; S 2453, Ensuring the Value of the 340B program Act of 2018, and S.2312, The HELP Act/. Also monitor MACPAC proposal to modify the Medicaid DSH allocation reduction statute. Monitor proposed CMS regulations affecting medicare outpatient payments for 340B and monitor congressional action on 340B.

Client expense: Not reported · Firm income: $10,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

No bill, lobbied to raise awareness about Atrial Fibrillation and stroke prevention. No bill, lobbied regarding biosimilars issues including naming, labeling and interchangeability. H.R. 1245 and S. 469, Affordable and Safe Prescription Drug Importation Act, lobbied regarding all biopharmaceutical provisions. H.R. 1703, Medical Product Communications Act of 2017, regarding all biopharmaceutical related provisions H.R. 2851, Stop the Importation and Trafficking of Synthetic Analogues Act of 2017, regarding all biopharmaceutical related provisions No bill, lobbied for changes to the 340B Drug Discount Program. H.R. 4710, 340B PAUSE Act, lobbied regarding all biopharmaceutical provisions. H.R. 4392, a bill to repeal the HOPPS final regulation related to changes in the payment amount for certain drugs under the 340B program, lobbied regarding all biopharmaceutical provisions. H.R. 2026, the Pharmaceutical Information Exchange (PIE) Act of 2017, lobbied regarding all biopharmaceutical provisions. S. 2312, Helping Ensure Low-Income Patients have Access to Care and Treatment (HELP) Act, regarding all biopharmaceutical related provisions. S.2453, Ensuring the Value of the 340B Program Act of 2018, regarding all biopharmaceutical related provisions. H.R. 5598 340B Optimization Act, regarding all biopharmaceutical related provisions. H.R. 6071 SERV Communities Act, regarding all biopharmaceutical related provisions. H.R. 6240, Drug Discount Accountability Act, regarding all biopharmaceutical related provisions. H.R. 6143, S. 2554, Patient Right to Know Drug Prices Act, regarding all biopharmaceutical related provisions. H.R. 6, SUPPORT for Patients and Communities Act, regarding all biopharmaceutical related provisions.

Client expense: $940,000 · Firm income: Not reported

Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), SENATE, U.S. Trade Representative (USTR)

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

SNP Reauthorization Act of 2017 (HR 3168); Creating High-Quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act of 2017 (S.870); Further Continuing and Security Assistance Appropriations Act (HR 2028); Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and 2019 draft Call Letter; the 340B Program (HR 4392, HR, 4710, and S. 2312); Community-Based Independence for Seniors Act of 2017 (HR 4006); Further Continuing and Security Assistance Appropriations Act (HR 2028); Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and 2019 draft Call Letter; RUSH Act (HR 6502) To amend title XVIII of the Social Security Act to establish a program to allow qualified group practices to furnish certain items and services at qualified skilled nursing facilities to individuals entitled to benefits under part A and enrolled under part B of the Medicare program to reduce unnecessary hospitalizations, and for other purposes. Advancing Care for Exceptional Kids Act HR 3325

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

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

ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed the proposed public charge rule and adding Medi-Cal to the list of programs that would be considered in making a public charge determination.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

ACE Kids: Support for the ACE Kids Act, S 428 and HR 3325, which seeks to make it easier for children with medical complexity to seek treatment across state lines. 340B: Sought the reversal of cuts to 340B reimbursements in the final Medicare Outpatient Prospective Payment System - H.R. 4392. Opposed measures that would limit expansions of the 340B program and require burdensome, irrelevant and unnecessary reporting by 340B covered entities - H.R. 4710, S. 2312, and S. 2453. Supported H.R. 6071 (Matsui) to require HHS to audit drug manufacturers and publish 340B ceiling prices. Opposed proposed public charge rule, which would punish children with disabilities and complex medical conditions, and make it harder for them to pursue lawful citizenship.

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

Government targets: HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE

P.L. 111-148 and P.L. 111-152 Affordable Care Act. All provisions related to implementation of health care reform including the Medicare and Medicaid programs, tax and insurance policies, graduate medical education, biomedical research, public and preventative health measures, and other policies concerning hospitals, physicians, health plans, employers and individuals. P.L. 115-120 Making Further Appropriations for Fiscal Year Ending September 30, 2018 and for other purposes. All provisions related to the Children's Health Insurance Program and Medicare Rural Hospital payments. H.R. 1892 Bipartisan Budget Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. H.R. 1625 Consolidated Appropriations Act of 2018. All provisions related to the Children's Health Insurance Program, Medicare, Medicaid disproportionate share hospital payments, biomedical research and medical education. 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. All Provisions. S 2312 Helping Ensure Low-Income Patients Have Access to Care and Treatment Act. All provisions related to the 340B drug discount program. H.R. 4710 Pause Act. All provisions related to the 340B drug discount program. H.R. 6 Support for Patients and Communities Act. All provisions related to Opioids. H.R. 5818 The Opioid Workforce Act of 2018. All provisions. S. 2843 The Opioid Workforce Act of 2018. All provisions. S. 1291 Advancing Medical Resident Training in Community Hospitals Act of 2017. All provisions. H.R. 4552 Advancing Medical Resident Training in Community Hospitals Act of 2017. All provisions. Ochsner Nominee for the Physician-Focused Payment Technical Advisory Committee. Centers for Medicare and Medicaid Hospital Outpatient Prospective Payment System proposed rule related to Section 603 of the Bipartisan Budget Act of 2015 applying site neutral payment policy to exempted off-campus hospital out-patient departments. All Provisions. Development of Value Based Payment Programs Digital Medicine/Health Programs

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

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

340B Drug Pricing issues H.R. 4392, a bill to prevent implementation of the 340B payment provision in the hospital OPPS rule. S.2312 - HELP Act Liver Transplant Proposals Kidney Dialysis and Transplant Anti-Rejection Medications

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

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

H.R. 4710 - 340B PAUSE Act; provisions relating to 340B drug pricing S. 2453 - Ensuring the Value of the 340B Program Act of 2018; provisions relating to 340B drug pricing S. 2312 - HELP Act; provisions relating to 340B drug pricing H.R. 6071 - SERV Communities Act; provisions relating to 340B drug pricing 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; provisions related to 340B drug pricing Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule comments/CAR-T therapy reimbursement

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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