PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA for PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA

Medicare/Medicaid MMM

H.R. 242: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation H.R. 849: Protecting Seniors Access to Medicare Act - Provisions related to repeal of the IPAB H.R. 1316: Prescription Drug Price Transparency Act - Provisions related to transparency of payment methodologies H.R. 3921: HEALTHY KIDS Act - Funding for the Childrens Health Insurance Program H.R. 3922: CHAMPIONING HEALTHY KIDS Act - CHIP and CHC reauthorization H.J.Res. 51: Approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S. 41: Medicare Prescription Drug Price Negotiation Act of 2017 - Provisions related to Part D and drug pricing negotiation S. 251: Protecting Medicare from Executive Action Act of 2017 - Provisions related to repeal of the Independent Patient Advisory Board (IPAB) S. 260: Protecting Seniors' Access to Medicare Act of 2017 - Provisions related to repeal of the IPAB S. 348: Prescription Drug and Health Improvement Act of 2017 - Provisions related to Part D S. 637: Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2017 - Provisions related to transparency of prescription drug pricing and pharmacy benefit managers S. 870: CHRONIC Care Act of 2017 - Provisions related to Medicare and chronic care S. 1348: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2017 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 1688: Empowering Medicare Seniors to Negotiate Drugs Prices Act of 2017 - Part D and non-interference provisions S. 1827: KIDS Act of 2017 - Funding for the Childrens Health Insurance Program S.J.Res. 16: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal S.J.Res. 17: A joint resolution approving the discontinuation of the process for consideration and automatic implementation of the annual proposal of the Independent Medicare Advisory Board under section 1899a of the Social Security Act - Provisions related to IPAB repeal Medicare Access and Childrens Health Insurance Program (CHIP) reauthorization policy issues Department of Health and Human Services (HHS) drug policy issues and regulatory policy issues Part D policy issues including non-interference and rebates policy issues Part B reform including MedPAC recommendations and other policy issues Drug cost and pricing policy issues Transparency policy issues Alternative payment models policy issues Value-based purchasing arrangements policy issues Anti-Kickback Statute policy issues Center for Medicare and Medicaid Innovation (CMMI) policy issues Medicaid rebates and waiver policy issues Prescription drug abuse policy issues Final Rule; Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC) - Revisions to the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 Proposed Rule: Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program (CMS-4182-P)

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

Bills named: H.R. 242 (115th), S. 1827 (115th), S. 41 (115th), S. 260 (115th), S. 348 (115th), H.R. 3921 (115th), S.J.Res. 17 (115th), S.J.Res. 16 (115th), H.R. 3922 (115th), S. 1688 (115th), H.R. 1316 (115th), S. 870 (115th), S. 251 (115th), S. 637 (115th), H.R. 849 (115th), S. 1348 (115th), H.J.Res. 51 (115th)

Budget/Appropriations BUD

H.R. 195: Making further continuing appropriation for the fiscal year ending September 30, 2018, and for other purposes. H.R. 1625: Consolidated Appropriations Act, 2018 H.R. 1892: Bipartisan Budget Act of 2018

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

Bills named: H.R. 1892 (115th), H.R. 195 (115th), H.R. 1625 (115th)

Health Issues HCR

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

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

Bills named: H.R. 1628 (115th), H.R. 2063 (115th), H.R. 5009 (115th), H.R. 1776 (115th), H.R. 2051 (115th), S. 2312 (115th), H.R. 2851 (115th), H.R. 5353 (115th), H.R. 2871 (115th), H.R. 4482 (115th), H.R. 2026 (115th), S. 2589 (115th), H.R. 4275 (115th), S. 469 (115th), H.R. 1480 (115th), H.R. 5327 (115th), H.R. 449 (115th), H.R. 5247 (115th), H.R. 5261 (115th), S. 64 (115th), H.R. 4710 (115th), S. 2456 (115th), H.R. 5102 (115th), H.R. 1703 (115th), H.R. 5041 (115th), H.R. 749 (115th), H.R. 2212 (115th), S. 92 (115th), H.R. 3692 (115th), H.R. 5311 (115th), S. 297 (115th), S. 974 (115th), S. 2553 (115th), H.R. 4284 (115th), H.R. 1231 (115th), H.R. 3545 (115th), H.R. 5202 (115th), S. 771 (115th), H.R. 5329 (115th), H.R. 1245 (115th), S. 1131 (115th), H.R. 878 (115th), H.R. 5228 (115th), S. 2453 (115th), S. 2554 (115th), H.R. 2025 (115th), S. 204 (115th), H.R. 5002 (115th)

Trade (domestic/foreign) TRD

Trade Agreements and related policy issues Biopharmaceutical innovation policy issues International intellectual property and market access policy issues Pricing and reimbursement policy issues Canada intellectual property and market access policy issues NAFTA policy issues Korea Trade Agreement (KORUS) policy issues

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

Copyright/Patent/Trademark CPT

H.R. 4117: Competitive Deals Resulting in Unleashed Generics and Savings Act of 2017 or the Competitive DRUGS Act of 2017 - Patent Settlements H.R. 5340: The Support Technology & Research for Our Nations Growth and Economic Resilience (STRONGER) Patents Act of 2018 - Provisions related to reforms of Patent Trial and Appeal Board (PTAB) proceedings and other patent system reforms S. 124: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 1390: STRONGER Patents Act of 2017 - Provisions related to reforms of PTAB proceedings and other patent system reforms 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. S. 1948: A bill to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents S. 2514: PACED Act - Provisions related to sovereign immunity and patents S. 2601: BIG Data for IP Act - Provisions related to fee-setting authority Biopharmaceutical innovation and patent policy issues Patent litigation reform issues and issues related to post-grant proceeding at the PTO Bayh-Dole march-in rights policy issues

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

Bills named: S. 1390 (115th), S. 1948 (115th), S. 2601 (115th), H.R. 4117 (115th), H.R. 5340 (115th), S. 1681 (115th), S. 2514 (115th), S. 124 (115th)