GENENTECH, INC for GENENTECH INC

Taxation/Internal Revenue Code TAX

Issues related to corporate tax reform. General Tax Issues.

Contacted: Health & Human Services, Dept of (HHS); SENATE; White House Office; Food & Drug Administration (FDA); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS)

Pharmacy PHA

340B Drug Discount Program.

Contacted: Centers For Medicare and Medicaid Services (CMS); Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Executive Office of the President (EOP); SENATE; Health & Human Services, Dept of (HHS); White House Office; Food & Drug Administration (FDA)

Trade (domestic/foreign) TRD

Trade negotiations, Transatlantic Trade and Investment Partnership (TTIP), NAFTA. Issues related to trade policy.

Contacted: HOUSE OF REPRESENTATIVES; Office of Management & Budget (OMB); SENATE; Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); White House Office

Copyright/Patent/Trademark CPT

Intellectual property and process patent issues. General IP issues. Patent litigation reform.

Contacted: Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); SENATE; Health & Human Services, Dept of (HHS); White House Office; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA)

Health Issues HCR

Provide guidance and strategic counsel with regard to regulations and legislation that could impact, pharmaceutical and biotechnology manufacturers. General education about policies impacting pharmaceutical development, approval, pricing and reimbursement S. 469 Affordable and Safe Prescription Drug Importation Act. S.204/H.R.878, Trickett Wendler Right to Try Act of 2017. Stockpiling of medical countermeasures in advance of a potential pandemic. H.R.1628, American Health Care Act of 2017/Better Care Reconciliation Act of 2017. H.R.2430/S.934, FDA Reauthorization Act of 2017, Prescription Drug User Fee Agreement Issues related to the 340B Program Issues related to the implementation of the follow-on biologics provisions in P.L. 111148 "Patient Protection and Affordable Care Act". Medicare Part B Demonstration Implementation issues related to the Distribution Quality, Security and Accountability Act (P.L. 113-54), HR6, 21st Century Cures Act, Issues related to Pharma supply chain, Senate HELP Innovation Project

Contacted: Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA); Office of Management & Budget (OMB); Centers For Medicare and Medicaid Services (CMS); SENATE; Executive Office of the President (EOP); White House Office; HOUSE OF REPRESENTATIVES

Bills named: H.R. 6 (115th), H.R. 2430 (115th), H.R. 1628 (115th), S. 934 (115th), S. 204 (115th), S. 469 (115th), H.R. 878 (115th)

Medicare/Medicaid MMM

Implementation of Medicare pharmaceutical coverage and reimbursement issues Policies relating to 340B Drug Discount Program Issues relating to the repeal and replacement of the Affordable Care Act (HR 1628, The American Health Care Act). Medicare Part B reimbursement issues for physicians and implementation of related provisions of MACRA Payment policies for prescription drugs

Contacted: Office of Management & Budget (OMB); White House Office; Food & Drug Administration (FDA); Executive Office of the President (EOP); HOUSE OF REPRESENTATIVES; Health & Human Services, Dept of (HHS); SENATE; Centers For Medicare and Medicaid Services (CMS)

Bills named: H.R. 1628 (115th)

Budget/Appropriations BUD

Issues related to FDA and HHS program funding in the FY17 Labor, Health and Human Services, and Education and Related Agencies, and FY17 Agriculture, Rural Developments, Food and Drug Administrations, and Related Agencies Appropriations bills. FY2018, Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; FY2018, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations; H.R.244, Consolidated Appropriations Act 2017 (P.L.115-31); vial size issues. Issues related to establishing the budget for the United States Government for FY 2018, Bipartisan Budget Act of 2015

Contacted: SENATE; Office of Management & Budget (OMB); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP); White House Office; Health & Human Services, Dept of (HHS); Food & Drug Administration (FDA)

Bills named: H.R. 244 (115th)

Medical/Disease Research/Clinical Labs MED

Issues related to the development of medical countermeasures for neurotoxins; Biomedical Advanced Research and Development Authority

Contacted: White House Office; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; Food & Drug Administration (FDA); Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); SENATE; Office of Management & Budget (OMB)