EXPRESS SCRIPTS, INC. for EXPRESS SCRIPTS, INC.

Trade (domestic/foreign) TRD

Trans Pacific Partnership trade agreements impact on biosimilar drugs market exclusivity length.

Contacted: Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Labor, Dept of (DOL); Health Resources & Services Administration (HRSA); Defense, Dept of (DOD); Congressional Budget Office (CBO); Internal Revenue Service (IRS); White House Office; U.S. Trade Representative (USTR); SENATE; Health & Human Services, Dept of (HHS); Government Accountability Office (GAO); Federal Trade Commission (FTC); Centers For Medicare and Medicaid Services (CMS); Executive Office of the President (EOP)

Taxation/Internal Revenue Code TAX

HR 4, Comprehensive 1099 Taxpayer Protection and Repayment of Exchange Subsidy Overpayments Act of 2011 Regulatory implementation of various tax provisions in the health reform legislation Repeal of the 3% tax withholding requirement for federal contractors

Contacted: Health Resources & Services Administration (HRSA); Defense, Dept of (DOD); Executive Office of the President (EOP); Government Accountability Office (GAO); Food & Drug Administration (FDA); Labor, Dept of (DOL); Federal Trade Commission (FTC); White House Office; U.S. Trade Representative (USTR); Health & Human Services, Dept of (HHS); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Internal Revenue Service (IRS); SENATE; Congressional Budget Office (CBO)

Bills named: H.R. 4 (112th)

Health Issues HCR

Regulatory policies related to health reform legislation: structure, drug benefits, disclosure Regulatory implementation of HITECH/Accounting of Disclosures FDA issues regarding making prescription drugs more affordable (generic user fees; pedigree; pathway for biosimilars; REMs)

Contacted: Labor, Dept of (DOL); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); HOUSE OF REPRESENTATIVES; Defense, Dept of (DOD); SENATE; Federal Trade Commission (FTC); White House Office; Government Accountability Office (GAO); Congressional Budget Office (CBO); Health & Human Services, Dept of (HHS); Executive Office of the President (EOP); Internal Revenue Service (IRS); Health Resources & Services Administration (HRSA); Centers For Medicare and Medicaid Services (CMS)

Medicare/Medicaid MMM

Health reform proposals that impact Medicare Part D such as formulary requirements, PBM disclosure provisions, closing of the Part D coverage gap. General reg/leg Part D issues such as direct negotiation (HR 2190, HR 2248, S 1206) & MTM expansion (HR 891/S 274). Statutory implementation of changes to the definition of AMP in Medicaid. Exclusion of specialty distributors' prompt pay discounts from the definition of Average Sales Price (HR 905/S 733). Policy considerations of the Jt. Comm on Deficit Reduc.

Contacted: Labor, Dept of (DOL); Defense, Dept of (DOD); Health & Human Services, Dept of (HHS); Congressional Budget Office (CBO); Internal Revenue Service (IRS); Federal Trade Commission (FTC); Executive Office of the President (EOP); White House Office; Health Resources & Services Administration (HRSA); SENATE; Centers For Medicare and Medicaid Services (CMS); HOUSE OF REPRESENTATIVES; U.S. Trade Representative (USTR); Government Accountability Office (GAO); Food & Drug Administration (FDA)

Bills named: H.R. 905 (112th), H.R. 891 (112th), H.R. 2190 (112th), H.R. 2248 (112th)

Labor Issues/Antitrust/Workplace LBR

Legislation to exempt certain pharmacies from the antitrust laws for purposes of negotiating with payers (HR 1409, HR 1946, HR 1839). Advocacy surrounding proposed corporate merger.

Contacted: Labor, Dept of (DOL); Congressional Budget Office (CBO); HOUSE OF REPRESENTATIVES; Centers For Medicare and Medicaid Services (CMS); Food & Drug Administration (FDA); Internal Revenue Service (IRS); SENATE; Defense, Dept of (DOD); Government Accountability Office (GAO); Health Resources & Services Administration (HRSA); Executive Office of the President (EOP); Health & Human Services, Dept of (HHS); Federal Trade Commission (FTC); White House Office; U.S. Trade Representative (USTR)

Bills named: H.R. 1409 (112th), H.R. 1839 (112th), H.R. 1946 (112th)

Pharmacy PHA

Policies related to the Federal Employees Health Benefit Program's pharmacy benefit (HR 979); Regulatory design and coverage of pharmacy benefits in health reform Exchanges and the commercial market (EHB, grandfathering, Rx quality, eRx, PBM disclosure requirements, MLR); legislation to promote generic drugs (S. 27); regulatory implementation of a pathway for the approval of biosimilars; REMs; 340b program; legislation placing restrictions on pharmacy benefit design (HR 1971, S 1058).

Contacted: Executive Office of the President (EOP); Centers For Medicare and Medicaid Services (CMS); Labor, Dept of (DOL); Defense, Dept of (DOD); White House Office; Federal Trade Commission (FTC); HOUSE OF REPRESENTATIVES; Congressional Budget Office (CBO); U.S. Trade Representative (USTR); Food & Drug Administration (FDA); Health & Human Services, Dept of (HHS); Health Resources & Services Administration (HRSA); Internal Revenue Service (IRS); Government Accountability Office (GAO); SENATE

Bills named: H.R. 1971 (112th), H.R. 979 (112th), S. 27 (112th)

Defense DEF

Issues related to Section 700 (Champus provisions) of the annual National Defense Authorization Act of 2012

Contacted: White House Office; Government Accountability Office (GAO); HOUSE OF REPRESENTATIVES; Defense, Dept of (DOD); Health Resources & Services Administration (HRSA); Congressional Budget Office (CBO); Federal Trade Commission (FTC); Food & Drug Administration (FDA); Internal Revenue Service (IRS); Centers For Medicare and Medicaid Services (CMS); Labor, Dept of (DOL); Executive Office of the President (EOP); U.S. Trade Representative (USTR); SENATE; Health & Human Services, Dept of (HHS)